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JDQ443 vs Docetaxel for Non-Small Cell Lung Cancer (KontRASt-02 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests
Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
Must not have
Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 33 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial compares two medicines to treat advanced NSCLC with KRAS G12C mutation after other treatments.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer that has a specific mutation (KRAS G12C) and who have already tried platinum-based chemo and immune therapy. They can't join if they've had certain lung conditions, other mutations like EGFR or ALK, active brain metastases, or previous treatment with docetaxel or KRAS G12C inhibitors.
What is being tested?
The study compares JDQ443 alone to the chemotherapy drug docetaxel in patients whose lung cancer has worsened despite prior treatments. It's an open-label phase III trial where participants are randomly assigned to one of the two drugs.
What are the potential side effects?
JDQ443 side effects aren't fully known yet but may be similar to other targeted therapies which include diarrhea, skin issues, and liver enzyme changes. Docetaxel can cause hair loss, nausea, fatigue, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a KRAS G12C mutation.
Select...
My cancer is at an advanced stage (stage IIIB/IIIC or IV).
Select...
I've had one platinum-based chemotherapy and one immune therapy for my advanced cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has EGFR mutation or ALK rearrangement.
Select...
I have cancer that has spread to my brain or spinal cord.
Select...
I have a history of severe lung inflammation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately up to 33 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately up to 33 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival (PFS)
Secondary study objectives
Change from baseline in EORTC-EQ-5D-5L
Change from baseline in EORTC-QLQ-C30
Change from baseline in EORTC-QLQ-LC13
+11 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: JDQ443Experimental Treatment1 Intervention
Participants will be treated with JDQ443
Group II: DocetaxelActive Control1 Intervention
Participant will be treated with docetaxel following local guidelines as per standard of care and product labels

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,909 Previous Clinical Trials
4,209,974 Total Patients Enrolled

Media Library

Docetaxel (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05132075 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Docetaxel, JDQ443
Non-Small Cell Lung Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT05132075 — Phase 3
Docetaxel (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05132075 — Phase 3
~28 spots leftby Nov 2025
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