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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Hunan Cancer Hospital
RECRUITING
Changsha
Contact Information
Primary
Yongchang Zhang, MD
zhangyongchang@csu.edu.cn
+8613873123436
Backup
Nong Yang, MD
yangnong0217@163.com
+8613873123436
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2027-10-10
Participants
Target number of participants: 760
Treatments
Experimental: Arm A: EGFR mutant Group
EGFR mutant Group.
Experimental: Arm B: ALK fusion Group
ALK fusion Group.
Experimental: Cohort C: ROS1 fusion Group.
ROS1 fusion Group.
Related Therapeutic Areas
Sponsors
Leads: Hunan Province Tumor Hospital