Phase 2
N=9
Binimetinib and Hydroxychloroquine in Patients With Advanced KRAS Mutant Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer · KRAS Mutation-Related Tumors
Bottom Line
View on ClinicalTrials.gov: NCT04735068 ↗Enrolled (actual)
9
Serious AEs
44.4%
Results posted
Apr 2025
Primary outcome: Primary: Objective Response Rate — 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Binimetinib Pill (Drug); Hydroxychloroquine Pill (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate |
9 | — |
| PRIMARY Number of Patients With Adverse Events |
9 | — |
| SECONDARY Progression-free Survival (PFS) |
1 | — |
| SECONDARY Overall Survival (OS) |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Metastatic or incurable NSCLC
- Presence of a non-synonymous mutation in KRAS
- Patient must have received at least one prior systemic therapy for metastatic NSCLC or be intolerant/ineligible/refuse available therapies with known benefit
- Ability and willingness to sign a written informed consent document
- Age ≥18 years old
- At least one measureable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- ECOG performance status 0-1
- Adequate organ function
- Women of childbearing potential must have a negative serum pregnancy test performed within 72hours of the first dose of study therapy. Subjects of reproductive potential must agree to use acceptable birth control methods (see Appendix B for childbearing potential).
- Qtc 30 days prior to randomization are eligible.
- History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within 6 months prior to randomization.
- Ejection fraction of ≤50% as measured by echocardiography or MUGA
- Any other conditions judged by the investigator that would limit the evaluation of the subject
Data sourced from ClinicalTrials.gov (NCT04735068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.