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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 below

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My cancer has a KRAS G12C mutation.

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My cancer is at an advanced stage (stage IIIB/IIIC or IV).

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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

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

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 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%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,860 Previous Clinical Trials

4,197,949 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this experiment?

"Absolutely, clinicaltrials.gov has data which substantiates that this study is currently seeking volunteers. This research was initially published on June 15th 2022 and went through its most recent update on June 8th 2023. A total of 360 participants need to be enrolled for the trial at 73 different sites."

Answered by AI

Are any new participants still being accepted for this clinical experiment?

"Per the medical records available on clinicaltrials.gov, this trial is currently accepting enrollees and was initially posted back in June 15th of 2022 with its last update being made a year later."

Answered by AI

Has JDQ443 been tested in any previous research studies?

"Currently, JDQ443 is the subject of 289 studies, many of which are in their third phase. Although most research for this drug originates from Fuzhou, Fujian province, it is being investigated all across 22690 sites worldwide."

Answered by AI

Has JDQ443 been granted clearance by the Food and Drug Administration?

"We have rated JDQ443 with a score of 3 on the safety scale due to its Phase 3 status, which demonstrates promising evidence regarding efficacy and numerous assessments affirming its security."

Answered by AI

To what conditions is JDQ443 typically administered?

"JDQ443 is frequently prescribed for malignant neoplasms, but has been used to address a variety of medical issues such as metastatic hormone-refractory prostate cancer, advance directives, and sarcoma."

Answered by AI

What is the geographic scope of this research project?

"This medical research is being conducted in 73 different facilities located across the world, with notable centres based in Pilar, Cluj Napoca and Levis. Ideally, participating patients should select a site that is closest to them to reduce travel expenses."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05132075.

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