Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06305754

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs).

The primary hypotheses of this study is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Adventista Belgrano-Oncology ( Site 0315), Caba., Buenos Aires, Argentina

Loading trial locations.

About this study

Participants will be randomized 1:1 into two arms:

  • Sacituzumab tirumotecan
  • Pemetrexed plus Carboplatin

Participants will receive treatment until any of the criteria for discontinuation of study intervention are met.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
  • Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
  • Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
  • Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
  • Life expectancy of at least 3 months.

Exclusion criteria

  • Predominantly squamous cell histology NSCLC.
  • History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
  • Grade ≥2 peripheral neuropathy.
  • History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
  • Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
  • Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
  • Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
  • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
  • Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Active infection requiring systemic therapy.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Concurrent active HBV and HCV infection.
  • History of allogeneic tissue/solid organ transplant.
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Treatment and study plan

Sacituzumab tirumotecan

Biological

4 mg/kg via IV infusion

Other names: SKB264, MK-2870

Pemetrexed

Drug

500 mg/m^2 via IV infusion

carboplatin

Drug

AUC 5 mg/mL*min via IV infusion

H1 receptor antagonist

Drug

Administered as rescue medication per approved product label

H2 receptor antagonist

Drug

Administered as rescue medication per approved product label

Acetaminophen (or equivalent)

Drug

Administered as rescue medication per approved product label

Dexamethasone (or equivalent)

Drug

Administered as rescue medication per approved product label

Steroid mouthwash (dexamethasone or equivalent)

Drug

Administered as rescue medication per approved product label

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 51 months

    Overall survival is defined as the time from randomization to death due to any cause. Overall survival for all randomized participants will be reported.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to approximately 51 months

    Progression-Free Survival is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first. PFS for all randomized participants will be reported.

  2. Objective Response Rate (ORR)

    Time frame: Up to approximately 51 months

    The objective response rate (ORR) is defined as a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR. The overall response rate for all randomized participants will be reported.

  3. Duration of Response (DOR)

    Time frame: Up to approximately 51 months

    For participants who demonstrate confirmed CR or PR per RECIST 1.1 as assessed by BICR, duration of response is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. CR is defined as the disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions.

  4. Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score

    Time frame: Baseline and up to approximately 6 years

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the Global Health Status (GHS) question "How would you rate your overall health during the past week?" (Item 29) and the Quality of Life (QoL) question "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A higher value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be reported.

  5. Change From Baseline in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30

    Time frame: Baseline and up to approximately 6 years

    The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the question "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized so that scores range from 0 to 100. A higher value indicates increased severity of symptoms. Change from baseline in dyspnea (EORTC QLQ-C30 Item 8) will be reported.

  6. Change from Baseline in the Cough (Item 31) Score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13)

    Time frame: Baseline and up to approximately 6 years

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates increased severity of symptoms. Change from baseline in cough (EORTC QLQ-LC13 Item 31) will be reported.

  7. Change from Baseline in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13

    Time frame: Baseline and up to approximately 6 years

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates increased severity of symptoms. Change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented.

  8. Time to Deterioration (TTD) in Global Health Status/Quality of Life (Items 29 and 30) Combined Score, on the EORTC QLQ-C30

    Time frame: Baseline and up to approximately 6 years

    EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Items 29 and 30 ("How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. TTD in Global Health Status (GHS)/Quality of Life (QoL) is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in combined GHS/QoL score. The TTD in GHS/QoL (Items 29 and 30) combined score will be reported.

  9. TTD in the Dyspnea (Item 8) Score, on the EORTC QLQ-C30

    Time frame: Baseline and up to approximately 6 years

    EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to the question for Item 8 "Were you short of breath?" are scored on a 4-point scale (1=Not at All to 4=Very Much). TTD is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in score. The TTD in dyspnea score (EORTC QLQ-C30 Item 8) will be reported.

  10. TTD in the Cough (Item 31) Score, on the EORTC QLQ-LC13

    Time frame: Baseline and up to approximately 6 years

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question for Item 31 "How much did you cough?" are scored on a 4-point scale (1=Not at All to 4=Very Much). TTD is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in score. The TTD in cough score (EORTC QLQ-C30 Item 31) will be reported.

  11. TTD in the Chest Pain (Item 40) Score, on the EORTC QLQ-LC13

    Time frame: Baseline and up to approximately 6 years

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question for Item 40 "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. TTD is defined as the time from baseline to the first onset of a ≥10-point decrease from baseline in score. The TTD in chest pain score (EORTC QLQ-C30 Item 40) will be reported.

  12. Number of Participants Who Experience One or More Adverse Events (AEs)

    Time frame: Up to approximately 6 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience one or more AEs will be reported.

  13. Number of Participants Who Discontinue Study Treatment Due to an AE

    Time frame: Up to approximately 6 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Mar 12, 2024
Registry last updated
Jul 20, 2026

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.