Clinical trial · Interventional
Phase 1b/2 Trial of AMG386 With Pemetrexed and Carboplatin in Non-Small Cell Lung Cancer
A Phase 1b/2 Trial of AMG 386 in Combination With Pemetrexed and Carboplatin as First Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
NCT01666977CI-TRIAL-00022480completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this phase 1b/2 study is to estimate the treatment effect of study drug measuring progression free survival.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 386 | Drug | — | UNRESOLVED |
| AMG 386 Placebo | Drug | — | UNRESOLVED |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Arm A: AMG 386 placebo IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
- interventionNames
- Drug: AMG 386 Placebo
- Drug: Pemetrexed
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Arm B: AMG 386 15 mg/kg IV QW, pemetrexed 500 mg/m2 IV Q3W, carboplatin AUC 6 IV Q3W, for up to 6 cycles
- interventionNames
- Drug: AMG 386
- Drug: Pemetrexed
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed, unresectable stage IV non-squamous non small cell lung cancer (NSCLC) * Radiographically evaluable disease (measurable or non-measurable) per RECIST 1.1 with modifications * Adequate hematological, renal, and hepatic function, normal coagulation profile, calculated CrCL ≥ 45 mL/min * Other criteria may apply Exclusion Criteria: * Any prior chemotherapy or targeted therapy for non-squamous NSCLC * Subjects with adenosquamous histology or any histology subtype containing greater than 10% squamous cells * Subjects with an epidermal growth factor receptor (EGFR) mutation sensitive to treatment with a tyrosine kinase inhibitor (TKI) * Subjects with known anaplastic lymphoma kinase (EML4-ALK) translocations * History or presence of central nervous system metastases * Central (chest) radiation therapy within 28 days prior to enrollment/randomization, radiation therapy to any other site(s) within 14 days prior to enrollment/randomization * History of pulmonary hemorrhage or gross hemoptysis within 6 months * History of arterial or venous thromboembolism within 12 months * History of clinically significant bleeding within 6 months * Clinically significant cardiovascular disease within 12 months * Other criteria may apply
References
Publications (0)
Data not yet available
No reference posted for this study.