- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05284539
Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer (Awesome)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators want to evaluate the Efficacy 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.
This study will be divided into three cohorts. Cohort A for EGFR mutation NSCLC, Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included.
Cohort B for ALK fusion NSCLC, Patient with NGS identified ALK fusion NSCLC who failed from first line Alectinib/Lorlatinib/Ceritinib/Ensartinib/Brigatinib will be included. All the patients will be divided two group,3'ALK and 3'ALK with retention of 5'ALK.
Cohort C for ROS1 fusion NSCLC, Patient with NGS identified ROS1 fusion NSCLC who failed from first line Crizotinib/Entrectinib/Ensartinib/Brigatinib will be included.
The investigators will collect the safety and efficacy data for all the patients.
The tissue and blood samples will be collected under the permission of the participate.
Single cell sequencing, DSP, RNA-seq and IHC will be performed to evaluate the TME.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Yongchang Zhang, MD
- Phone Number: 7+861383123436 +8613873123436
- Email: zhangyongchang@csu.edu.cn
Study Contact Backup
- Name: Nong Yang, MD
- Phone Number: +8613873123436 +8613873123436
- Email: yangnong0217@163.com
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Recruiting
- Hunan Cancer Hospital
-
Contact:
- Yongchang Zhang, MD
- Phone Number: +86 731 89762323
- Email: zhangyongchang@csu.edu.cn
-
Contact:
- Nong Yang, MD
- Phone Number: +86 731 89762321
- Email: yangnong0217@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Description
Inclusion Criteria:
- Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
- Age ≥ 18 years.
- Histologically or cytologically confirmed, Stage IV NSCLC.
- EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
- ECOG 0-1.
- Predicted survival ≥ 12 weeks.
- Adequate bone marrow hematopoiesis and organ function
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: EGFR mutant Group
EGFR mutant Group.
|
Pemetrexed, 500mg/m2, ivgtt, every 21 days.
Bevacizumab 15mg/kg, ivgtt, every 21 days.
Pembrolizumab, 200mg ivgtt, every 21 days.
Atezolizumab, 1200mg, ivgtt, every 21 days.
Other Names:
|
Experimental: Arm B: ALK fusion Group
ALK fusion Group.
|
Pemetrexed, 500mg/m2, ivgtt, every 21 days.
Bevacizumab 15mg/kg, ivgtt, every 21 days.
Pembrolizumab, 200mg ivgtt, every 21 days.
Atezolizumab, 1200mg, ivgtt, every 21 days.
Other Names:
|
Experimental: Cohort C: ROS1 fusion Group.
ROS1 fusion Group.
|
Pemetrexed, 500mg/m2, ivgtt, every 21 days.
Bevacizumab 15mg/kg, ivgtt, every 21 days.
Pembrolizumab, 200mg ivgtt, every 21 days.
Atezolizumab, 1200mg, ivgtt, every 21 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Time from first subject dose to study completion, or up to 36 month
|
To assess progression-free survival of patients treated with Immune Checkpoint Inhibitor, Bevacizumab in combination with Chemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause
|
Time from first subject dose to study completion, or up to 36 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events (AEs) according to CTCAE 5.0
Time Frame: From first dose until 28 days after the last dose, up to 24 month
|
Number of participants with adverse events (AEs) according to CTCAE 5.0
|
From first dose until 28 days after the last dose, up to 24 month
|
Overall survival (OS)
Time Frame: Time from first subject dose to study completion, or up to 36 month
|
To assess overall survival, define as first dose to the death of the subject due to any cause
|
Time from first subject dose to study completion, or up to 36 month
|
Objective Response Rate (ORR)
Time Frame: Time from first dose to last dose, or up to 24 month
|
To assess PD-1 antibody, Bevacizumab in combination with Chemotherapy overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
|
Time from first dose to last dose, or up to 24 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Yongchang Zhang, MD, Hunan Cancer Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Immune Checkpoint Inhibitors
- Folic Acid Antagonists
- Bevacizumab
- Pembrolizumab
- Pemetrexed
- Atezolizumab
Other Study ID Numbers
- 20220117
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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