FLUX-CT-2023-01: Novel Combination Therapy for Advanced NSCLC
This Phase II study evaluates the efficacy and safety of a novel combination therapy (FLUX-291 + standard of care) in patients with advanced non-small cell lung cancer (NSCLC) who have progressed on first-line therapy. The trial employs a randomized, double-blind, placebo-controlled design with a primary endpoint of progression-free survival. Secondary endpoints include overall survival, objective response rate, and quality of life measures. The study will enroll 120 patients across 15 sites with a 24-month treatment period and 6-month follow-up.
Based on analysis of similar protocols and recent publications, the current visit schedule could be optimized to reduce patient burden while maintaining data quality. The secondary endpoint of quality of life could benefit from using the latest EORTC QLQ-C30 version instead of the specified version.
Protocol Timeline
Inclusion/Exclusion Criteria
Key Inclusion Criteria
Histologically or cytologically confirmed diagnosis of stage IIIB or IV NSCLC
Age ≥ 18 years
Disease progression during or after first-line therapy containing platinum-based chemotherapy
Key Exclusion Criteria
Prior treatment with FLUX-291 or similar agents targeting the same pathway
Known active CNS metastases and/or carcinomatous meningitis
ECOG performance status > 2
Study Procedure Schedule
Key Procedures by Visit
| Procedure | Screening | Day 1 | Week 4 | Week 8 | Week 12 |
|---|---|---|---|---|---|
| Informed Consent | — | — | — | — | |
| Medical History | — | — | — | ||
| Physical Examination | |||||
| Vital Signs | |||||
| CT Scan | — | — | — | ||
| Study Drug Administration | — |
Key Endpoints
AI-Generated Protocol Insights
Latest Insights
Based on analysis of protocol text, related literature, and similar trials
Protocol Inconsistency
The CT scan frequency in the Schedule of Assessments (section 8.1) differs from the description in the Imaging section (10.3). The former indicates Q8W while the latter states Q12W.
Recent Literature Update
A recent meta-analysis (published Mar 2025) supports the combination therapy approach in this protocol and suggests considering PRO-CTCAE for patient-reported outcomes.
Optimization Opportunity
Patient burden could be reduced by combining the Week 4 and Week 8 assessments, as data indicates minimal clinical changes between these timepoints in similar studies.
Regulatory Update
Recent FDA guidance (Feb 2025) for oncology trials recommends enhanced monitoring for immune-related adverse events when combining agents like those in this protocol.
Protocol Query
Based on protocol section 9.3 "Adverse Event Reporting", the key requirements are:
- All AEs occurring from the time of signed informed consent through 30 days after the last dose must be reported
- SAEs must be reported within 24 hours of investigator awareness
- AESIs (immune-related AEs, infusion reactions) must be reported regardless of causality assessment
- All AEs must be graded according to NCI-CTCAE v5.0
- Follow-up of unresolved AEs should continue until resolution or stabilization
Related Protocol Documents
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