Clinical trial · Interventional
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)
A Randomized Discontinuation Phase II Trial of Ridaforolimus in Non-Small Cell Lung Cancer (NSCLC) Patients With KRAS Mutations
- 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)
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.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Blinded Placebo | Drug | — | UNRESOLVED |
| Comparator: Blinded Ridaforolimus | Drug | — | UNRESOLVED |
| Lead-In Ridaforolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ridaforolimus
- interventionNames
- Drug: Lead-In Ridaforolimus
- Drug: Comparator: Blinded Ridaforolimus
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Drug: Lead-In Ridaforolimus
- Drug: Comparator: Blinded Placebo
Primary outcomes (1)
- measure
- Progression-free survival (PFS) in the randomized population
- timeFrame
- Randomization (Week 8) and every 8 weeks until progressive disease or death
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available