A Phase II, Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of GSK1120212 Compared with Docetaxel in 2nd Line Subjects with Targeted Mutations (KRAS, NRAS, BRAF, MEK1) in Locally Advanced or Metastatic Nonsmall Cell Lung Cancer (MEK114653)

Phase 2

Completed

• Conditions: non-small cell lung cancer; NSCLC; 10029107

• Registration Number: NL-OMON38298
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

• Males and females >=18 years of age.
• Histologically/cytologically-confirmed adenocarcinoma Stage IIIBwet (with confirmed malignant pleural effusion) or Stage IV NSCLC with a positive mutational status for the KRAS, NRAS, BRAF, or MEK1 gene.
• Documented tumor progression after receiving at least one, but not more than one, prior approved platinum-containing chemotherapy regimen for advanced stage/metastatic NSCLC.
a. Erlotinib maintenance therapy following first-line treatment with any approved platinum-containing chemotherapy is allowed.
b. Pemetrexed maintenance therapy is only allowed following a first-line treatment with cisplatin or carboplatin and pemetrexed.
c. Patients who have received any treatment (e.g., erlotinib, chemotherapy, or Investigational Agents) in a second-line setting are not allowed.
• Measurable disease.
• ECOG performance status 0-1.
• Safe contraception for male participants with a partner of childbearing potential or female participants of childbearing potential.

Exclusion Criteria

• Other malignancy. See protocol for exceptions.
• CNS manifestations.
• Treatment with a BRAF or MEK-inhibitor or docetaxel (monotherapy or combination therapy).
• Anti-cancer treatment in the past 3 weeks.
• Prior or current evidence/risk of retinal vein occlusion or central serous retinopathy. See protocol for details.
• Prior or current increased CVS risk.
• Known HIV, hepatitis B-C infection.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression-free survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Adverse reactions, response rate, duration of response, overall survival, PK.</p><br>