NCT05284539 Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer
| NCT ID | NCT05284539 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Hunan Province Tumor Hospital |
| Condition | Non Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 760 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 760 participants in total. It began in 2022-04-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Yongchang Zhang, MD
PRINCIPAL INVESTIGATOR
Hunan Cancer Hospital
Frequently Asked Questions
Who can join the NCT05284539 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05284539 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05284539 currently recruiting?
Yes, NCT05284539 is actively recruiting participants. Contact the research team at zhangyongchang@csu.edu.cn for enrollment information.
Where is the NCT05284539 trial being conducted?
This trial is being conducted at Changsha, China.
Who is sponsoring the NCT05284539 clinical trial?
NCT05284539 is sponsored by Hunan Province Tumor Hospital. The principal investigator is Yongchang Zhang, MD at Hunan Cancer Hospital. The trial plans to enroll 760 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.