A Study of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutations (MK-8669-021 AM1)

Phase 2

Terminated

Brief Summary: This is a randomized discontinuation study of ridaforolimus in patients with advanced NSCLC who have failed at least 1 but no more than 3 prior treatment regimens and who have KRAS mutant lung cancer. Following 8 weeks of open-label ridaforolimus lead-in there will be an assessment of disease status. Patients assessed by the investigator to have stable disease after 8 weeks will be randomized to double-blind treatment with ridaforolimus or placebo. Patients assessed to have partial or complete response will continue on open-label ridaforolimus. Patients assessed to have disease progression will be discontinued from study.

Detailed Description: Allocation and Arms Additional Information: All Patients will receive an 8-week

open-label lead-in treatment of ridaforolimus. After this 8 week period patients will be re-assessed for disease status. Patients who are stable after 8 weeks are randomized in a double-blind fashion to continue treatment with ridaforolimus or to a placebo until disease progression. (Those patients who have stable disease but are randomized to placebo may cross-over to open-label ridaforolimus at the time of disease progression.)

Those patients with tumor shrinkage during the open-label lead-in treatment will continue on open-label ridaforolimus, while those patients who have disease progression at 8-weeks are taken off-study.

Recruitment & Eligibility

Inclusion Criteria

Patient has histologically confirmed stage IIIB/IV non-small cell lung cancer
Patient has a documented mutation of the KRAS gene
Patient has evidence of disease progression following 1 but no more than 3 prior chemotherapy regimens
A minimum of 4 weeks has passed since the most recent anti-cancer treatment
Women of childbearing potential must have a negative pregnancy test prior to start of therapy and must use an approved contraceptive method for the duration of the study
Patient has adequate organ function
Patient has performance status of <=2 on Eastern Cooperative Oncology Group (ECOG) performance scale
Patient is >=18 years of age

Exclusion Criteria

Patient has received more than 2 prior chemotherapy regimens for the treatment lung cancer
Patient is known to have active brain metastases
Patient is currently participating or has participated in an investigational drug study within 30 days
Patient is known to be Human Immunodeficiency Virus (HIV) positive or has a known history of Hepatitis B or C
Patient has an active infection requiring prescribed intervention
Patient has newly diagnosed or un-controlled Type 1 or 2 diabetes

Arm && Interventions

Group	Intervention	Description
Placebo	Lead-In Ridaforolimus	-
Ridaforolimus	Lead-In Ridaforolimus	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS) in the randomized population	Randomization (Week 8) and every 8 weeks until progressive disease or death

Secondary Outcome Measures

Name	Time	Method
PFS in the full analysis population	Study entry (Visit 1) and every 8 weeks until progressive disease or death
Overall response rate (ORR) in the full analysis population	Study entry (Visit 1) and every 8 weeks until progressive disease or death
OS in the randomized population	From study entry (Visit 1) to death due to any cause
Overall survival (OS) in the full analysis population	From study entry (Visit 1) to death due to any cause

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