Non-Small Cell Lung CancerPhase 3KontRASt-02NCT05132075
Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer
A Phase 3 study testing JDQ443 and docetaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 51 sites in 25 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- JDQ443 and docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 51 sitesin 25 countries
- Study dates
- 15 Jun 2022to 5 Oct 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- 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.
- Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
- Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
Who cannot join
- Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
- 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
- Participant has an history of interstitial lung disease or pneumonitis grade > 1.
- Other inclusion/exclusion criteria may apply
Trial locations and contacts
51 sites in 25 countries.
51 sites in 25 countries
China8 sites
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Changsha, Hunan, 410013
Novartis Investigative Site
Fuzhou, Fujian, 350014
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Novartis Investigative Site
Harbin, Heilongjiang, 150081
Novartis Investigative Site
Jinan, Shandong, 250117
Novartis Investigative Site
Shengyang, Liaoning, 110042
Turkey (Türkiye)6 sites
Novartis Investigative Site
Adana, Adana, 01140
Novartis Investigative Site
Ankara, Ankara, 06680
Novartis Investigative Site
Ankara, Bilkent Cankaya, 06800
Novartis Investigative Site
Ankara, Yenimahalle, 06500
Novartis Investigative Site
Istanbul, Fatih, 34093
Novartis Investigative Site
Istanbul, Pendik, 34899
Spain4 sites
Novartis Investigative Site
Córdoba, 14004
Novartis Investigative Site
Madrid, 28009
Novartis Investigative Site
Oviedo, Principality of Asturias, 33011
Novartis Investigative Site
Pamplona, Navarre, 31008
Greece3 sites
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 115 26
Novartis Investigative Site
Heraklion Crete., 715 00
Italy3 sites
Novartis Investigative Site
Aviano, PN, 33081
Novartis Investigative Site
Lucca, LU, 55100
Novartis Investigative Site
Roma, RM, 00128
Argentina2 sites
Novartis Investigative Site
CABA, Buenos Aires, C1414DRK
Novartis Investigative Site
Pilar, Buenos Aires, B1629AHJ
Australia2 sites
Novartis Investigative Site
Auchenflower, Queensland, 4066
Novartis Investigative Site
South Brisbane, Queensland, 4101
Canada2 sites
Novartis Investigative Site
Montreal, Quebec, H4A 3J1
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4
Hong Kong2 sites
Novartis Investigative Site
Hong Kong, 999077
Novartis Investigative Site
Kowloon, 999077
India2 sites
Novartis Investigative Site
Delhi, 110085
Novartis Investigative Site
Jaipur, Rajasthan, 302019
Malaysia2 sites
Novartis Investigative Site
Kuala Lumpur, 59100
Novartis Investigative Site
Kuching, Sarawak, 93586
Portugal2 sites
Novartis Investigative Site
Matosinhos Municipality, 4454-513
Novartis Investigative Site
Porto, 4100-180
United States1 site
Valley Medical Center Research
Renton, Washington, 98055
South Korea1 site
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: KontRASt-02: A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC)
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.
Read the detailed description
The study was designed as a multi-center, open-label, randomized, active-controlled, Phase III trial.
Participants were randomized to either JDQ443 or docetaxel. Participants randomized to the docetaxel arm had the opportunity to cross over to JDQ443 at disease progression per RECIST 1.1 by local investigator assessment.
The study population included adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who had received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.
Approximately 360 participants were planned to be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status. Following the decision to halt enrollment for business reasons, a total of 95 participants were randomized.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- JDQ443, docetaxel
- Keywords
- NSCLC, Non small cell lung cancer, Lung cancer, Cancer of the lung, Cancer of lung, Pulmonary Cancer, Neoplasms, Lung, Neoplasms, Pulmonary
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JDQ443Drug
JDQ443 tablets, orally administered
docetaxelDrug
docetaxel concentrated solution for infusion, intravenously administered
| Study group | Role | What they receive |
|---|---|---|
| JDQ443 | Experimental | Participants treated with JDQ443 Receives: Drug: JDQ443 |
| Docetaxel | Active comparator | Participant treated with docetaxel following local guidelines as per standard of care and product labels Receives: Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
PFS is the time from date of randomization to the date of event defined as the first documented disease progression based on local Investigator assessment per RECIST 1.1 criteria or death due to any cause.
Measured: Approximately up to 24 months
Secondary outcomes (1)
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs (any AEs regardless of seriousness) and SAEs, including changes from baseline in vital signs, electrocardiograms and laboratory results qualifying and reported as AEs.
Measured: Approximately up to 25 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start15 Jun 2022
- Primary completion3 Sep 2026
- Study completion5 Oct 2026
Why it stopped: Business reasons and not based on any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132075
- Sponsor's protocol ID
- CJDQ443B12301
- Other IDs
- 2023-510082-10-00, 2023
- Acronym
- KontRASt-02
- Status last verified
- Nov 2026
- First submitted
- 11 Nov 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KontRASt-02: A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT05132075
- Acronym / sponsor ID
- KontRASt-02 / CJDQ443B12301
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Non small cell lung cancer, Lung cancer, Cancer of the lung, Cancer of lung, Pulmonary Cancer, Neoplasms, Lung, Neoplasms, Pulmonary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business reasons and not based on any safety concerns.
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 5 Oct 2026 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was designed as a multi-center, open-label, randomized, active-controlled, Phase III trial.
Participants were randomized to either JDQ443 or docetaxel. Participants randomized to the docetaxel arm had the opportunity to cross over to JDQ443 at disease progression per RECIST 1.1 by local investigator assessment.
The study population included adult participants with locally advanced or metastatic (stage IIIB/IIIC or IV) KRAS G12C mutant non-small cell lung cancer (by tissue or plasma as determined by a Novartis-designated central laboratory or accepted local tests) who had received prior platinum-based chemotherapy and prior immune checkpoint inhibitor therapy administered either in sequence or as combination therapy.
Approximately 360 participants were planned to be randomized to JDQ443 or docetaxel in a 1:1 ratio stratified by prior line of therapy and ECOG performance status. Following the decision to halt enrollment for business reasons, a total of 95 participants were randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JDQ443 | Experimental | Drug: JDQ443Participants treated with JDQ443 |
| Docetaxel | Active comparator | Drug: docetaxelParticipant treated with docetaxel following local guidelines as per standard of care and product labels |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
- 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.
- Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
- Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.
Key exclusion criteria (5 listed)
- Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
- 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
- Participant has an history of interstitial lung disease or pneumonitis grade > 1.
- Other inclusion/exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JDQ443JDQ443 tablets, orally administered | Drug | JDQ443 |
| docetaxeldocetaxel concentrated solution for infusion, intravenously administered | Drug | Docetaxel |
Primary outcome
Progression free survival (PFS)
Time frame: Approximately up to 24 months
PFS is the time from date of randomization to the date of event defined as the first documented disease progression based on local Investigator assessment per RECIST 1.1 criteria or death due to any cause.
1 secondary outcome
Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Approximately up to 25 months
Results and safety
The study was stopped early (reason given: Business reasons and not based on any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.
Related trials for Non-Small Cell Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
51 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JDQ443 and docetaxel in people with Non-Small Cell Lung Cancer, run by Novartis Pharmaceuticals at 51 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in China, Turkey (Türkiye), Spain, Greece, Italy and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Business reasons and not based on any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: Approximately up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.