Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer

Phase 2 Completed 9 enrolled Abramson Cancer Center at Penn Medicine Pfizer · collab

NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate using hydroxychloroquine (HCQ) along with binimetinib as an effective method for treating cancer. All patients will receive binimetinib at a standard dose approved for other cancers. The dose of HCQ will also be fixed based on ongoing phase I studies. Eligible subjects will have lung cancer that has a mutation in a key cancer gene called KRAS, and the cancer has spread to other parts of their body.

Timeline

Start: 2021-04-09
Primary completion: 2022-08-21
Completion: 2023-12-31

Outcome

Missed primary endpoint

paper The best response was stable disease in one patient (11.1%). PMID 37186063 ↗

paper The combination of B + HCQ in second- or later-line treatment of patients with advanced KRAS-mutant NSCLC did not show significant antitumor activity. PMID 37186063 ↗

Publications

Aggarwal C, Maity AP, Bauml JM, Long Q, Aleman T, Ciunci C, D'Avella C, Volpe M, Anderson E, Jones LM, Sun L, Singh AP, Marmarelis ME, Cohen RB, Langer CJ, Amaravadi R. A Phase II Open-Label Trial of Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS-Mutant Non-Small Cell Lung Cancer. Oncologist. 2023 Jul 5;28(7):644-e564. doi: 10.1093/oncolo/oyad106.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Binimetinib	Small molecule	45 mg	Oral
Subject	Hydroxychloroquine	Small molecule	400 mg	Oral