Clinical trial · Interventional

Radiotherapy Combined With ICIs as Treatment for LA-NSCLC After Failing Induction Immunochemotherapy

Radiotherapy Combined With Immune Checkpoint Inhibitors (ICIs) as Treatment for Locally Advanced Non-small-cell Lung Cancer After Failing Induction Immuno-chemotherapy: a Prospective, Real-world Cohort Study.

NCT06031597CI-TRIAL-00069594unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Patients with stage III non-small-cell lung cancer initially evaluated as unresectable are selected for the program, who are remained unresectable after 2-4 cycles of conversion chemotherapy combined with immune checkpoint inhibitors. Investigators will stratify the treatment according to different performance status scores and radiotherapy plan bi-lung receptor volume to evaluate the safety and efficacy of immunotherapy followed by combined radiotherapy.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Non-small Cell Lung Cancer Stage III	Lung Non-Small Cell Carcinoma	CURATED_BROADER	0.78

Interventions

Interventions (4)

Intervention	Type	Mapped drug	Match
Immunotherapeutic Agent	Drug	—	UNRESOLVED
Immunotherapy	Drug	Immunotherapy	ALIAS
Platinum-Based Drug	Drug	—	UNRESOLVED
radiotherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
EXPERIMENTAL
label
Cohort A: concurrent chemoradiotherapy combined with ICIs
description
For performance status (PS)=0-1 and both lungs V20≤20%, mean lung dose (MLD)≤11 gray(Gy), then the patient should be treated with concurrent chemo-radiotherapy and immunotherapy, and immunotherapy should be given after chemo-radiotherapy to maintain up to 1 year. Participants eligible for enrollment will receive radiotherapy within 8 weeks of the end of chemotherapy combined with Immune checkpoint inhibitors (ICIs) at a radical prescribed dose of 60 Gy ± 10% at 2 Gy once daily for 5 days per week. The chemotherapy regimen will be cisplatin at a dose of 25 mg/m2 once a week for 5-6 cycles. Marketed programmed cell death 1 (PD-1) or programmed cell death L1 (PD-L1) inhibitors are chosen as immunotherapy agents. Immunotherapy will be given every 3 weeks, with no more than 3 cycles of immunotherapy during radiotherapy. The dosage is recommended according to the drug insert.
interventionNames
1. Radiation: radiotherapy
2. Drug: Platinum-Based Drug
3. Drug: Immunotherapy
4. Drug: Immunotherapeutic Agent
type
EXPERIMENTAL
label
Cohort B: concurrent radiotherapy combined with ICIs
description

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

Inclusion Criteria:

1. Histologically or cytologically confirmed non-small cell lung cancer
2. Presence of at least one measurable lesion according to RECIST 1.1 criteria
3. Classified as American Joint Committee on Cancer staging system, eighth edition (AJCC-8) Stage III, initially evaluated as unresectable and reevaluated as unresectable after 2-4 cycles of induction chemotherapy combined with immunotherapy
4. Age 18-75
5. Eastern Cooperative Oncology Group (ECOG) physical state score of 0-2
6. Patients with the pathologic type of adenocarcinoma should be negative for driver genes (EGFR, anaplastic lymphoma kinase, ROS1)
7. Serum hemoglobin ≥ 90 g/L, platelets ≥ 90 × 109/L, absolute neutrophil count ≥ 1.2 × 109/L
8. Serum creatinine ≤ 1.25 times upper limit of normal(ULN) or creatinine clearance ≥ 60 mL/min
9. Serum bilirubin ≤ 1.5 times ULN, (AST) and alanine aminotransferase aspartate aminotransferase (ALT) ≤ 2.5 times ULN, alkaline phosphatase ≤ 5 times ULN
10. Forced expiratory volume in one second (FEV1)\>0.8 liter
11. Normal coagulation function (Prothrombin time prolonged by no more than 3s and activated partial thromboplastin time prolonged by no more than 10s)
12. Patients signed a formal informed consent form to indicate that they understood that the study complied with the hospital's policies and ethical requirements

Exclusion Criteria:

1. The pathologic type is lung carcinoid or small cell lung cancer
2. Patients with any distant metastases
3. Grade 2 or higher unresolved toxic effects after conversion therapy (according to the Common Terminology Criteria for Adverse Events CTCAE)
4. A recent efficacy rating of PD after conversion therapy
5. Radiotherapy plan for normal lung tissue V20 \> 30%, or average lung dose MLD \> 17 Gy
6. Active or previous autoimmune disease (within the past 2 years) or history of primary immunodeficiency
7. Patients with any other previous or current malignancy, except non-melanoma skin or cervical cancer in situ
8. Any other disease or condition suggesting a contraindication to radiotherapy (e.g., active infection, within 6 months of myocardial infarction, symptomatic cardiac disease including unstable angina pectoris, congestive heart failure, or uncontrolled arrhythmias, immunosuppressive therapy)
9. Pregnant or nursing women
10. Women and men who are at risk of becoming pregnant but are unwilling to use adequate contraception
11. Evidence of hereditary bleeding disorders or coagulation disorders.

References

Publications (0)

Data not yet available

No reference posted for this study.