Clinical trial · Interventional
A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC
A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-squamous Non-small Cell Lung Cancer
NCT00369070CI-TRIAL-00031021terminatedPhase 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 study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.
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 |
|---|---|---|---|
| Advanced Non-squamous NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 706 | Drug | Motesanib | ALIAS |
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- A
- description
- AMG 706 125 mg once daily (QD) and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
- interventionNames
- Drug: AMG 706
- Drug: Paclitaxel
- Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- B
- description
- AMG 706 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days and paclitaxel and carboplatin chemotherapy regimen (paclitaxel 200 mg/m2 and carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3 week cycle for a maximum of 6 cycles.
- interventionNames
- Drug: AMG 706
- Drug: Paclitaxel
- Drug: Carboplatin
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent) * Measureable disease per RECIST criteria modified * ECOG performance status of 0 or 1 * Ability to take oral medications * Competent to give written informed consent Exclusion Criteria: * Current or prior history of CNS metastases * Any prior chemotherapy for advanced NSCLC * History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization * Prior targeted therapies * Known history of allergy or hypersensitivity to paclitaxel or carboplatin * History of arterial or venous thrombosis within 52 weeks prior to randomization * History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization * Peripheral neuropathy \> grade 1 per CTCAE Version 3.0 * Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization * Any kind of disorder that compromises the ability of the subject to comply with the study procedures * Uncontrolled hypertension as defined by resting blood pressure \> 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization. * Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization * Pregnant or breast feeding women * Known to be HIV, hepatitis B surface antigen, or hepatitis C positive
References
Publications (3)
- BACKGROUNDBlumenschein GR Jr, Kabbinavar F, Menon H, Mok TSK, Stephenson J, Beck JT, Lakshmaiah K, Reckamp K, Hei YJ, Kracht K, Sun YN, Sikorski R, Schwartzberg L; Motesanib NSCLC Phase II Study Investigators. A phase II, multicenter, open-label randomized study of motesanib or bevacizumab in combination with paclitaxel and carboplatin for advanced nonsquamous non-small-cell lung cancer. Ann Oncol. 2011 Sep;22(9):2057-2067. doi: 10.1093/annonc/mdq731. Epub 2011 Feb 14. PMID 21321086
- BACKGROUNDClaret L, Lu JF, Bruno R, Hsu CP, Hei YJ, Sun YN. Simulations using a drug-disease modeling framework and phase II data predict phase III survival outcome in first-line non-small-cell lung cancer. Clin Pharmacol Ther. 2012 Nov;92(5):631-4. doi: 10.1038/clpt.2012.78. Epub 2012 Aug 22. PMID 22910440
- DERIVEDBass MB, Yao B, Hei YJ, Ye Y, Davis GJ, Davis MT, Kaesdorf BA, Chan SS, Patterson SD. Challenges in developing a validated biomarker for angiogenesis inhibitors: the motesanib experience. PLoS One. 2014 Oct 14;9(10):e108048. doi: 10.1371/journal.pone.0108048. eCollection 2014. PMID 25314641