Clinical trial · Interventional
Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer
Efficacy of Platinum-based Chemotherapy With or Without Immune Checkpoint Inhibitors in Patients With EGFR/ALK/ROS1 Sensitive Mutated NSCLC Who Progressed From Previous Tyrosine Kinase Inhibitors (TKI) Therapy
NCT05284539CI-TRIAL-00077803AwesomerecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
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 | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: EGFR mutant Group
- description
- EGFR mutant Group.
- interventionNames
- Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab
- type
- EXPERIMENTAL
- label
- Arm B: ALK fusion Group
- description
- ALK fusion Group.
- interventionNames
- Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab
- type
- EXPERIMENTAL
- label
- Cohort C: ROS1 fusion Group.
- description
- ROS1 fusion Group.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form. 2. Age ≥ 18 years. 3. Histologically or cytologically confirmed, Stage IV NSCLC. 4. EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy. 5. ECOG 0-1. 6. Predicted survival ≥ 12 weeks. 7. Adequate bone marrow hematopoiesis and organ function 8. Presence of measurable lesions according to RECIST 1.1. Exclusion Criteria: Cancer-Specific Exclusions: * Active or untreated central nervous system metastases. * Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome. General Medical Exclusions: * Pregnant or lactating women. * History of autoimmune disease. * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Positive test for human immunodeficiency virus. * Active hepatitis B or hepatitis C. * Severe infection within 4 weeks prior to randomization. * Significant cardiovascular disease. * Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures. Exclusion Criteria Related to Medications: • Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.
References
Publications (0)
Data not yet available
No reference posted for this study.