Chemotherapy in KRAS mutated chemotherapy naive non-small cell lung cancer patients: a phase III study comparing cisplatin-pemetrexed with carboplatin-paclitaxel-bevacizumab: NVALT 22

Phase 3

Recruiting

• Conditions: Non-small cell lung cancer; KRAS mutation; 10038666

• Registration Number: NL-OMON55867
• Lead Sponsor: Stichting NVALT studies

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 240

Inclusion Criteria

Histologically or cytologically confirmed NSCLC (Stage IIIB or IV)
Documented KRAS mutation
Chemotherapy-naive NSCLC patients
ECOG PS 0-2
Age 18 years or older
Adequate bone marrow, hepatic and renal function

Exclusion Criteria

Pregnant or lactating women
Active cardiovascular disease
History of hemoptysis greater or equal to grade 2
Evidence of tumor invading major blood vessels on imaging

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To investigate in KRAS mutated patients with incurable NSCLC whether<br /><br>carboplatin-paclitaxel-bevacizumab results in a prolonged progression free<br /><br>survival compared to cisplatin-pemetrexed as first line treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To investigate differences in overall response rate (ORR) and disease control<br /><br>rate<br /><br>- To investigate differences in overall survival<br /><br>- To investigate differences in outcome between different subtypes of KRAS<br /><br>mutations<br /><br>- To investigate response by Crabb criteria</p><br>