Also known as: advanced NSCLC
Candel initiated the Phase 3 AURORA trial of aglatimagene in NSCLC and plans a Q4 2026 BLA in localized prostate cancer, with a potential 2027 launch. The company also appointed a Chief Commercial Officer.
ORIC selected rinzimetostat 400 mg plus darolutamide for the Himalayas-1 Phase 3 trial in post-abiraterone mCRPC, expected to start in 1H 2026. The company reported early efficacy and safety data and said cash runway extends into 2H 2028.
Krystal Biotech said IOLITE enrollment for KB803 is complete and it remains on track for KB803 and KB801 registrational data readouts in 2026. The company also reported FDA platform technology designations for KB407 and KB111 and continued VYJUVEK expansion.
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
A Phase 3 trial shows administering immunochemotherapy before 3:00 PM improves survival outcomes in advanced NSCLC. Early treatment resulted in 11.3 months progression-free survival versus 5.7 months for late treatment, and 28.0 months overall survival versus 16.8 months. The findings suggest treatment timing is a modifiable factor that can enhance efficacy without additional cost.
Candel Therapeutics secured $100M royalty funding for CAN-2409 and plans a Q4 2026 BLA submission in prostate cancer. Updated NSCLC phase 2a data showed median overall survival of 25.4 months, with a phase 3 trial planned for Q2 2026.
The FDA is accelerating its review of daraxonrasib, a targeted therapy for pancreatic cancer, under a new pilot program that could reduce approval time from 10-12 months to one to two months.
Moffitt Cancer Center researchers published findings on plant-based diets and cancer risk, identified spatial tumor-immune patterns predicting immunotherapy response, and hosted a summit on engineering-driven cancer research innovations.
A prospective multicenter study found that baseline gut microbiome diversity selectively stratifies benefit from dual checkpoint blockade in advanced NSCLC, with high diversity associated with prolonged survival on immunotherapy alone while low diversity patients benefit from added chemotherapy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07768358 |
Tucatinib Continuation Study |
NOT_YET_RECRUITING | PHASE4 |
| NCT07668037 |
Characterization of Multi-Omics Landscapes and AI Pathological Prediction Model for Long-Term Survival in NSCLC Immunotherapy |
RECRUITING | |
| NCT07652736 |
A Study to Investigate Treatment Patterns and Effectiveness of Tislelizumab in European Patients With Resectable or Advanced Non-Small Cell Lung Cancer (NSCLC) and Small Cell Lung Cancer (SCLC) |
RECRUITING | |
| NCT07415005 |
Lorlatinib Plus Local Consolidation Therapy In ALK Positive Advanced Non-Small Cell Lung Cancer |
RECRUITING | PHASE2 |
| NCT07392073 |
Peripheral Blood ETASTs for Predicting Efficacy of Chemoimmunotherapy in NSCLC |
NOT_YET_RECRUITING | |
| NCT07222566 |
Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer |
RECRUITING | PHASE3 |
| NCT07154290 |
A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC) |
RECRUITING | PHASE2 |
| NCT07105176 |
HS-IT101 Injection for Advanced NSCLC |
NOT_YET_RECRUITING | PHASE1 |
| NCT07090499 |
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors |
RECRUITING | PHASE1 |
| NCT06980272 |
SSGJ-707 in Advanced Non-Small Cell Lung Cancer |
RECRUITING | PHASE3 |
