Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (KontRASt-02)
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- STATUS
- Recruiting
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- End date
- May 29, 2025
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- participants needed
- 360
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- sponsor
- Novartis Pharmaceuticals
Summary
This is a phase III open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.
Description
The study has been designed as a Phase III trial and consists of 2 parts:
- Randomized part will evaluate the efficacy and safety of JDQ443 as monotherapy in comparison with docetaxel.
- Extension part will be open after final progression-free survival (PFS) analysis (if the primary endpoint has met statistical significance) to allow participants randomized to docetaxel treatment to crossover to receive JDQ443 treatment.
The study population will include adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue as determined by a Novartis-designated central laboratory) who have received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.
Approximately 360 participants will be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status.
Details
| Condition | Non-Small Cell Lung Cancer |
|---|---|
| Treatment | docetaxel, JDQ443 |
| Clinical Study Identifier | NCT05132075 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 7 October 2022 |
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