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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06159790 | A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) | PHASE3 | COMPLETED | 218 | — | — | Apr 29, 2024 | Mar 16, 2026 | Apr 9, 2026 | 62 | United States, Bosnia and Herzegovina +14 |
Best Overall Response (BOR) of either Complete Response (CR) or Partial Response (PR) up to 9 months according to RECIST 1.1 as assessed by Blinded Central Imaging
| Arm | Type | Description |
|---|---|---|
| GME751 + pemetrexed + carboplatin or cisplatin | EXPERIMENTAL | Participants will receive GME751 + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| Keytruda-EU + pemetrexed + carboplatin or cisplatin | ACTIVE_COMPARATOR | Participants will receive Keytruda-EU + pemetrexed + carboplatin or cisplatin via intravenous (IV) infusion. |
| Name | Type | Description |
|---|---|---|
| GME751 | DRUG | Drug: GME751 Concentrate for solution for infusion, Biologic, Liquid in vial, 100 mg, 200 mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion) |
| Keytruda-EU | DRUG | Drug: Keytruda-EU Concentrate for solution for infusion, biologic, liquid in vial, 100 mg, 200mg every 3 weeks, i.v. infusion Drug: Pemetrexed (i.v. infusion) Drug: Carboplatin or Cisplatin (i.v. infusion) |
Inclusion Criteria: * At least 18 years of age * Untreated metastatic NSCLC * Absence of tumor activating EGFR mutations and absence of ALK gene rearrangements * Measurable disease according to RECIST 1.1 * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status score...