Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06162572 | Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC) | PHASE1 | ACTIVE NOT_RECRUITING | 102 | — | — | Aug 7, 2024 | Jul 1, 2027 | May 11, 2026 | 63 | United States, Argentina +12 |
Part A
Part A
Part A
Part A
Part A
Part B: Participants who achieve complete response (CR) or partial response (PR), as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| S095018 (anti-TIM3 antibody) in combination with cemiplimab | EXPERIMENTAL | Part A: Combination-therapy safety lead-in |
| S095024 (anti-CD73 antibody) in combination with cemiplimab | EXPERIMENTAL | Part A: Combination-therapy safety lead-in |
| S095029 (anti-NKG2A antibody) in combination with cemiplimab | EXPERIMENTAL | Part A: Combination-therapy safety lead-in |
| S095018 (anti-TIM3 antibody) RDE in combination with cemiplimab | EXPERIMENTAL | Part B: Randomized dose expansion |
| S095024 (anti-CD73 antibody) RDE in combination with cemiplimab | EXPERIMENTAL | Part B: Randomized dose expansion |
| S095029 (anti-NKG2A antibody) RDE in combination with cemiplimab | EXPERIMENTAL | Part B: Randomized dose expansion |
| Cemiplimab (control arm) | ACTIVE_COMPARATOR | Part B: Randomized dose expansion |
| Name | Type | Description |
|---|---|---|
| S095018 | DRUG | Via IV infusion on Day 1 of each 21-day cycle |
| S095024 | DRUG | Via IV infusion on Day 1 of each 21-day cycle |
| S095029 | DRUG | Via IV infusion on Day 1 of each 21-day cycle |
| S095018 Recommended Dose Expansion (RDE) | DRUG | Via IV infusion on Day 1 of each 21-day cycle |
| S095024 RDE | DRUG | Via IV infusion on Day 1 of each 21-day cycle |
| S095029 RDE | DRUG | Via IV infusion on Day 1 of each 21-day cycle |
| Cemiplimab | DRUG | 350 mg via IV infusion on Day 1 of each 21-day cycle |
Inclusion Criteria: * Adult patient aged ≥ 18 years * Written informed consent * Histologically (squamous or non-squamous) or cytologically documented locally advanced NSCLC not eligible for surgical resection and/or definitive chemoradiation, or metastatic NSCLC * No prior systemic treatment for l...