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Completed

NCT Number: NCT04951063

Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC

This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-small cell lung cancer confirmed by histology.
  • Tumor size is measured according to RECIST standard.
  • Unresectable stage IIIA (N2) and IIIB/IIIC, confirmed by PET-CT/or chest and abdomen CT, brain MRI, and whole body bone scan.
  • 18-75 years old, regardless of gender.
  • The ECOG score is 0-1.
  • Newly treated or underwent neoadjuvant chemotherapy and/or immunotherapy.
  • Have not received chest radiotherapy in the past.
  • Serum hemoglobin ≥10 mg/dL, platelets ≥100000/μL, absolute neutrophil count ≥1500/μL.
  • Serum creatinine ≤1.25 times UNL or creatinine clearance ≥60 ml/min.
  • Serum bilirubin ≤1.5 times UNL, AST (SGOT) and ALT (SGPT) ≤2.5 times UNL, alkaline phosphatase≤ 5 times UNL.
  • FEV1>1 L.
  • CB6 normal range.
  • The patient and his family members agree and sign an informed consent form.

Exclusion criteria

  • Other malignant tumors in the past or during treatment, except for non-melanoma of the skin or carcinoma in situ of the cervix.
  • Any other diseases or conditions are contraindications to chemotherapy (such as active infection, within 6 months after myocardial infarction, symptomatic heart disease, including unstable angina, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy).
  • Pregnant or breastfeeding women, women who have not undergone a pregnancy test (within 14 days before the first dose), and pregnant women.
  • Those who are pregnant, breastfeeding or have fertility but have not taken contraceptive measures.
  • People with bleeding tendency.
  • Those who participated in other clinical trials within 30 days before participating in this experiment.
  • Drug addiction, long-term alcoholism, and AIDS patients.
  • People with uncontrollable seizures or loss of self-control due to mental illness.
  • People with a history of severe allergies or specific physique.
  • The researcher believes that the patient is inappropriate to participate in this trial.

Exit criteria

  • The treatment cannot be carried out in accordance with the requirements of the research protocol;
  • The patient has an allergic reaction ≥ grade 4 or a serious adverse reaction to the study drug;
  • The patient is pregnant or has not used adequate contraceptive measures;
  • The researcher judges that the patient should not continue to participate the clinical trial;
  • The subject asked to withdraw.

Treatment and study plan

Hypofractionated radiotherapy

Radiation

Split-course adaptive HRT-CHT is administered at the following three dose levels:

  • Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course,DT 1500cGy/5 daily fractions/300cGy in the second course;
  • Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course, DT 2000cGy/5 daily fractions/400cGy in the second course;
  • Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course, DT 3000cGy/6 daily fractions/500cGy in the second course.

Concurrent chemotherapy

Drug

weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT

Consolidation immunotherapy

Drug

Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.

Primary outcomes

  1. the maximally tolerated fraction dose

    Time frame: 1 year

    The maximum tolerated fraction dose was defined as the highest DL in which <=2 patients of the 6 treated patients experienced G3+ toxicity and <=1 patient experienced G4+ toxicity within 12 months after RT. If a patient had multiple types of toxicities, only the highest grade of toxicity was counted.

Secondary outcomes

  1. Objective response rate

    Time frame: 2 months after radiotherapy

    Proportion of patients with PR and CR at 2 months after radiotherapy

  2. Overall survival

    Time frame: 1-year

  3. Progression-free survival

    Time frame: 1-year

  4. Distant-metastasis free survival

    Time frame: 1-year

  5. Loco-regional recurrence-free survival

    Time frame: 1-year

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Fraction Dose Escalation of Hypofractionated Radiotherapy With Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: a Phase 1 Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2021
Registry last updated
Dec 15, 2023

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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