A Study of MM-121 in Combination With Chemotherapy Versus Chemotherapy Alone in Heregulin Positive NSCLC

Phase 2 Terminated 153 enrolled Elevation Oncology Merrimack Pharmaceuticals · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether the combination of MM-121 plus docetaxel is more effective than docetaxel alone in regards to PFS in patients with heregulin-positive NSCLC.

Timeline

Start: 2015-02-01
Primary completion: 2019-01-02
Completion: 2019-01-02

Outcome

Missed primary endpoint

Stopped: “Based on the preliminary results seen during interim analysis, which were confirmed in the final analysis, the Sponsor terminated the study”

registry analysis (superiority test); Arm A (Experimental): MM-121 in Combination With Docetaxel vs Arm B (Comparator): Docetaxel Alone; p = 0.2302; Hazard Ratio (HR) 1.382 (95% CI 0.813 to 2.350); Log Rank NCT02387216 ↗

Publications

Sequist LV, Gray JE, Harb WA, Lopez-Chavez A, Doebele RC, Modiano MR, Jackman DM, Baggstrom MQ, Atmaca A, Felip E, Provencio M, Cobo M, Adiwijaya B, Kuesters G, Kamoun WS, Andreas K, Pipas JM, Santillana S, Cho BC, Park K, Shepherd FA. Randomized Phase II Trial of Seribantumab in Combination with Erlotinib in Patients with EGFR Wild-Type Non-Small Cell Lung Cancer. Oncologist. 2019 Aug;24(8):1095-1102. doi: 10.1634/theoncologist.2018-0695. Epub 2019 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	—	—
Subject	Seribantumab	Monoclonal antibody	—	—