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JDQ443 vs Docetaxel for Non-Small Cell Lung Cancer (KontRASt-02 Trial)
Phase 3
Recruiting
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately up to 33 months
Awards & highlights
KontRASt-02 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.Check my eligibility
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.See study design
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.
KontRASt-02 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
KontRASt-02 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately up to 33 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately up to 33 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Change from baseline in EORTC-EQ-5D-5L
Change from baseline in EORTC-QLQ-C30
Change from baseline in EORTC-QLQ-LC13
+11 moreSide effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
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
KontRASt-02 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
2,868 Previous Clinical Trials
4,199,516 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had docetaxel or KRAS G12C inhibitors for advanced cancer, or if I did, my cancer didn't worsen within 12 months after treatment.My cancer has EGFR mutation or ALK rearrangement.I have cancer that has spread to my brain or spinal cord.You have at least one spot that can be measured or seen on a scan at the screening visit.My cancer has a KRAS G12C mutation.You have at least one spot that can be measured and evaluated by doctors.My cancer is at an advanced stage (stage IIIB/IIIC or IV).I have a history of severe lung inflammation.I've had one platinum-based chemotherapy and one immune therapy for my advanced cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Docetaxel
- Group 2: JDQ443
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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