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Completed

NCT Number: NCT04712903

Durvalumab Plus Chemotherapy in Untreated Patients With Extensive-Stage Small Cell Lung Cancer

This is a Phase IIIb, interventional, single arm, multicentre study to evaluate safety, effectivenees, use of resources and patient reporting outcomes in patients with ES-SCLC treated with durvalumab in combination with platinum-etoposide as first-line treatment in Spain.

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Key information

Conditions

Small Cell Lung Carcinoma Extensive Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, A Coruña, Spain

Loading trial locations.

About this study

This trial will provide an opportunity to further evaluate the safety profile and efficacy of durvalumab + EP in patient population that is reflective of real-world clinical practice, Durvalumab will be concurrently administered with first-line chemotherapy (EP) on an every 3 week (q3w) schedule for 4 to 6 cycles, and will continue to be administered as monotherapy post-chemotherapy on an every 4 week (q4w) schedule until confirmed progressive disease (PD) or unacceptable toxicity.

Prophylactic cranial irradiation (PCI) is allowed in patients showing complete or partial responses after the durvalumab + EP combination cycles, at the discretion of the investigator according to their local clinical practice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented Small cell Lung Cancer with extensive disease.
  • Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
  • Brain metastases; must be asymptomatic or have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent.
  • Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC.
  • ECOG Performance Status of 0-2 at enrolment.
  • No prior exposure to immune-mediated therapy for cancer.
  • Adequate hematologic and organ function.
  • Life expectancy of at least 12 weeks.
  • Body weight >30 kg.

Exclusion criteria

  • Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy (except paliative care outside of the chest).
  • Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
  • Active infection including tuberculosis, HIV, hepatitis B anc C
  • Active or prior documented autoimmune or inflammatory disorders
  • Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.

Treatment and study plan

Durvalumab

Drug

Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.

Cisplatin

Drug

Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.

etoposide

Drug

Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.

carboplatin

Drug

Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.

Primary outcomes

  1. Number of Patients With Adverse Events (AEs) Grade ≥ 3

    Time frame: During study treatment, until disease progression (median 6 months)

    Patients with AEs grade ≥ 3 acording to NCI CTCAE v5.0

  2. Number of Patients With Immune-mediated Adverse Events (imAE)

    Time frame: During study treatment, until disease progression (median 6 months)

    Patients with immune-mediated adverse events (imAE) per patient

Secondary outcomes

  1. Progression Free Survival (PFS).

    Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years

    PFS: Defined as the time from the first date of treatment until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient withdraws from investigational product or receives another anticancer therapy prior to progression. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable assessment.

  2. Objetive Response Rate (ORR)

    Time frame: At least every 12 weeks, up to 18 monts

    Per Response Evaluation Criteria In Solid Tumors (RECIST v1.0) Criteria for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  3. Duration of Response (DoR)

    Time frame: From the date of first documented response until the first date of documented progression or death in the absence of disease progression, assessed up to 2 years.

    DoR: Defined as the time from the date of first documented response per RECIST1.1 until the first date of documented progression per RECIST1.1 or death in the absence of disease progression.

  4. Time to Treatment Discontinuation (TTD)

    Time frame: From the first date of treatment until the end of treatment date, assessed up to 2 years.

    TTD: Defined as the time from the first date of treatment until the end of treatment date.

  5. Overal Survival (OS)

    Time frame: From date of inclusion until the date of death, assessed up to 30 months

    OS: Defined as the time from the first date of treatment until death due to any cause. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive.

  6. PFS Rate at 6 Months

    Time frame: Every 12 weeks

    Percentage of participants remaining alive without disease progression at 6 months after initiation of study treatment.

  7. PFS Rate at 12 Months

    Time frame: Every 12 weeks

    Percentage of participants remaining alive without disease progression at 12 months after initiation of study treatment.

  8. DoR Rate at 12 Months

    Time frame: Every 12 weeks

    Percentage of responders remaining alive without disease progression at 12 months after first response.

  9. OS Rate at 6 Months

    Time frame: Every 12 weeks

    Percentage of participants remaining alive at 6 months after initiation of study treatment.

  10. OS Rate at 12 Months

    Time frame: Every 12 weeks

    Percentage of participants remaining alive at 12 months after initiation of study treatment.

  11. OS Rate at 18 Months

    Time frame: Every 12 weeks

    Percentage of participants remaining alive at 18 months after initiation of study treatment.

  12. EORTC QLQ-C30: Global Health Status Domain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  13. EORTC QLQ-C30: Physical Functioning Domain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  14. EORTC QLQ-C30: Role Functioning Domain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  15. EORTC QLQ-C30: Emotional Functioning Domain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  16. EORTC QLQ-C30: Cognitive Functioning Domain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  17. EORTC QLQ-C30: Social Functioning Domain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For each of these scales, scores range from 0 to 100. For the Global Health Status and the 5 functional scales a high score indicates better global health status/functioning and a positive change from baseline indicates improvement.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  18. EORTC QLQ-C30: Fatigue, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  19. . EORTC QLQ-C30: Pain, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  20. EORTC QLQ-C30: Nausea and Vomiting, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  21. EORTC QLQ-C30: Dyspnoea, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  22. EORTC QLQ-C30: Insomnia, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  23. EORTC QLQ-C30: Appetite Loss, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  24. EORCT QLQ-C30: Constipation, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  25. EORTC QLQ-C30: Diarrhoea, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  26. EORTC QLQ-C30: Financial Difficulties, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-C30 was administered on day 1 and on the final visit (last treatment visit). EORTC QLQ-C30 is a 30-item questionnaire used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical Functioning, Role Functioning, Cognitive Functioning, Emotional Functioning, Social Functioning), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrohea, Financial difficulties).

    For the 9 symptom scales, a high score indicates a higher level of symptoms, and a negative change from Baseline indicates an improvement in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  27. EORTC QLQ-LC13: Coughing, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  28. EORTC QLQ-LC13: Haemoptysis, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  29. EORTC QLQ-LC13: Dyspnoea, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  30. EORTC QLQ-LC13: Pain in Arm or Shoulder, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  31. EORTC QLQ-LC13: Pain in Other Parts, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  32. EORTC QLQ-LC13: Sore Mouth, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  33. EORTC QLQ-LC13: Peripheral Neuropathy, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  34. EORTC QLQ-LC13: Alopecia, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  35. EORTC QLQ-LC13: Dysphagia, Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

  36. EORTC QLQ-LC13: Chest Pain Item Change From Baseline to End of Treatment Visit

    Time frame: Baseline (cycle 1 day 1) and end of treatment visit.

    EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, haemoptysis, dyspnoea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication.

    Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

    Change from baseline is the difference in the score between the end of treatment visit and the first visit.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase IIIB, Single Arm Study, of Durvalumab in Combination With Platinum-Etoposide for Untreated Patients With Extensive-Stage Small Cell Lung Cancer Reflecting Real World Clinical Practice in Spain (CANTABRICO).

Acronym: CANTABRICO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 15, 2021
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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