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New hope for Hard-to-Treat lung cancer: targeted pill shows promise

NCT ID NCT05445843

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This study tests a new drug called JDQ443 in people with advanced lung cancer that has a specific genetic change (KRAS G12C mutation) and does not respond well to standard treatments. The drug is taken as a pill and aims to shrink or control the cancer. About 95 participants will receive JDQ443 alone as their first treatment for advanced disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

95 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion criteria * Histologically confirmed locally advanced (stage IIIb/IIIc not eligible for definitive chemoradiation or surgical resection with curative intent) or metastatic (stage IV) NSCLC without previous systemic treatment for metastatic disease. Prior (neo)adjuvant treatment with chemotherapy and/or immunotherapy, or prior radiotherapy administered sequentially or concomitantly with chemotherapy and/or immunotherapy for localized or locally advanced disease are accepted if the time between therapy completion and enrollment is \> 12 months. * Presence of a KRAS G12C mutation (all participants) and: * Cohort A: PD-L1 expression \< 1%, regardless of STK11 mutation status * Cohort B: PD-L1 expression ≥ 1% and an STK11 co-mutation * At least one measurable lesion per RECIST 1.1. * ECOG performance status ≤ 1. * Participants capable of swallowing study medication. Key Exclusion criteria * Participants whose tumors harbor an EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other known druggable alterations will be excluded, if required by local guidelines * Previous use of a KRAS G12C inhibitor or previous systemic treatment for metastatic NSCLC. * A medical condition that results in increased photosensitivity (i.e., solar urticaria, lupus erythematosus, etc.). * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Participants who are taking a prohibited medication (strong CYP3A inducers) that cannot be discontinued at least seven days prior to the first dose of study treatment and for the duration of the study. Other inclusion/exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

lung neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic KRAS G12C-mutated NSCLC with A PD-L1 expression <1% or A PD-L1 expression ≥ 1% and an STK11 co-mutation

Contacts and locations

Locations

  • Novartis Investigative Site

    Pilar, Buenos Aires, B1629AHJ, Argentina

  • Novartis Investigative Site

    Córdoba, Córdoba Province, X5016KEH, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1426AGE, Argentina

  • Novartis Investigative Site

    Córdoba, X5000JHQ, Argentina

  • Novartis Investigative Site

    Feldkirch, 6807, Austria

  • Novartis Investigative Site

    Wels, 4600, Austria

  • Novartis Investigative Site

    Sint-Niklaas, Oost Vlaanderen, 9100, Belgium

  • Novartis Investigative Site

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Novartis Investigative Site

    Salvador, Estado de Bahia, 40170-110, Brazil

  • Novartis Investigative Site

    Belo Horizonte, 30360-680, Brazil

  • Novartis Investigative Site

    Rio de Janeiro, 22271-110, Brazil

  • Novartis Investigative Site

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    Changsha, Hunan, 410013, China

  • Novartis Investigative Site

    Beijing, 100036, China

  • Novartis Investigative Site

    Marseille, Bouches Du Rhone, 13915, France

  • Novartis Investigative Site

    Bron, 69677, France

  • Novartis Investigative Site

    Montpellier, 34070, France

  • Novartis Investigative Site

    Saint-Herblain, 44805, France

  • Novartis Investigative Site

    Strasbourg, 67091, France

  • Novartis Investigative Site

    Kempten (Allgäu), Bavaria, 87439, Germany

  • Novartis Investigative Site

    Halle, Saxony-Anhalt, 06120, Germany

  • Novartis Investigative Site

    Hamburg, 21075, Germany

  • Novartis Investigative Site

    Oldenburg, 26121, Germany

  • Novartis Investigative Site

    Tübingen, 72076, Germany

  • Novartis Investigative Site

    Athens, 11526, Greece

  • Novartis Investigative Site

    Mátraháza, 3200, Hungary

  • Novartis Investigative Site

    Thellakom Kottayam, Kerala, 686016, India

  • Novartis Investigative Site

    Varanasi, Uttar Pradesh, 221005, India

  • Novartis Investigative Site

    Bari, BA, 70124, Italy

  • Novartis Investigative Site

    Rozzano, MI, 20089, Italy

  • Novartis Investigative Site

    Roma, RM, 00128, Italy

  • Novartis Investigative Site

    Orbassano, TO, 10043, Italy

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Breda, North Brabant, 4818 CK, Netherlands

  • Novartis Investigative Site

    Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

  • Novartis Investigative Site

    Porto, 4100-180, Portugal

  • Novartis Investigative Site

    Barcelona, 08035, Spain

  • Novartis Investigative Site

    Madrid, 28041, Spain

  • Novartis Investigative Site

    Bangkok, 10700, Thailand

  • Novartis Investigative Site

    Istanbul, Bagcilar, 34214, Turkey (Türkiye)

  • Novartis Investigative Site

    Diyarbakır, Sur, 21280, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Torquay, TQ2 7AA, United Kingdom

  • The Brown University Oncology Group

    Providence, Rhode Island, 02903, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.