JDQ443 / Non Small Cell Lung Cancer / Docetaxel · Phase 3 Trial

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 3 registry record for a randomized, open-label comparison of JDQ443 versus docetaxel in KRAS G12C-mutant advanced NSCLC after prior platinum and immunotherapy. No results are posted in this registry record; the study remains active but not recruiting, with primary outcome (PFS) data collection ongoing.

What was studied

Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-Small Cell Lung Cancer; age from 18 Years; to 100 Years. Intervention: JDQ443. Compared with: Docetaxel — Active Comparator. n = 95. 51 sites across 25 countries.

Key findings

Safety

No efficacy, safety, or outcome results are reported in this registry record.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 3 trial registry record with no reported results; enrollment is complete but outcome data are not yet posted, making it a planned or ongoing study only.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Progression free survival (PFS) (assessed at Approximately up to 24 months)

DesignPhase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationNon-Small Cell Lung Cancer; age from 18 Years; to 100 Years

Sample size95

InterventionJDQ443

ComparatorDocetaxel — Active Comparator

Setting51 sites across 25 countries

Reported figures

Quoted from the source exactly as published.

Phase3

Primary endpointProgression free survival (PFS), approximately up to 24 months

Planned enrollment95

Study typeInterventional

BlindingOpen-label

Caveats

No efficacy, safety, or outcome results are reported in this registry record.
Open-label design may introduce detection and performance bias.
Actual sample size of 95 is substantially smaller than typical Phase 3 non-small cell lung cancer trials; statistical power for the primary endpoint is not stated.
Recruitment status is active but not recruiting; results timeline is unknown.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3 randomized open-label design appropriate for registration comparison.

Directness

strong

Directly compares JDQ443 monotherapy to standard-of-care docetaxel in target population.

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed.

Risk of bias

limited

Open-label design introduces detection bias; no blinding mentioned.

Sample adequacy

insufficient

Actual enrollment stated as 95 total; planned power analysis not reported in registry.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05132075). This is a study registration, not published results. Lead sponsor: Novartis Pharmaceuticals. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 95 participants (ACTUAL). Conditions: Non-Small Cell Lung Cancer. Interventions: DRUG: JDQ443; DRUG: docetaxel. Primary outcome measures: Progression free survival (PFS) , Approximately up to 24 months. Brief summary: This is a phase III randomized 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

JDQ443Non Small Cell Lung CancerNovartis PharmaceuticalsDocetaxelNCT05132075