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New pill shows promise against tough lung cancer mutations

NCT ID NCT06956001

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 14, 2026 · Updated 2 times

Summary

This study tests a new daily pill, firmonertinib, against standard chemotherapy for people with advanced non-small cell lung cancer that has certain EGFR mutations (PACC or L861Q). About 300 participants will be randomly assigned to receive either the pill or chemo. The goal is to see if the pill can delay cancer growth and improve quality of life.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jul 2028

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 years and older

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.

Inclusion Criteria: 1. Voluntarily sign the informed consent form (ICF). 2. Age ≥18 years at the time of ICF signing. 3. At least one measurable lesion per RECIST v1.1, meeting the following: * No prior local therapy (e.g., radiotherapy) * Not used for biopsy during screening 4. Histologically/cytologically confirmed non-squamous NSCLC, classified as: * Locally advanced (Stage IIIB/IIIC, unsuitable for curative surgery and/or definitive chemoradiotherapy) * Metastatic (Stage IV) (Based on UICC/AJCC 8th edition TNM staging) 5. Agreement to provide: * Recent tumor tissue (from untreated lesions) * Blood samples * Central lab-confirmed EGFR PACC or L861Q mutation (If tumor tissue is unavailable due to inaccessible lesions, sponsor consultation is required.) 6. No prior systemic therapy for advanced/metastatic NSCLC. * Allowed if: Prior (neo)adjuvant/definitive chemoradiotherapy completed ≥12 months before recurrence/progression 7. ECOG performance status 0-1. 8. Life expectancy ≥12 weeks. 9. Adequate bone marrow/organ function within 14 days before treatment (no transfusion/G-CSF within 2 weeks prior). 10. Women of childbearing potential (WOCBP): * Abstinence or contraception use * No egg donation 11. Non-sterilized males: * Abstinence or contraception use * No sperm donation 12. CNS metastases allowed if protocol-specified criteria are met. Exclusion Criteria: 1. Histologically/cytologically confirmed tumor with \>10% neuroendocrine carcinoma, sarcomatoid carcinoma, or squamous cell components. 2. Known ALK-positive, ROS1-positive, RET fusion-positive, NTRK fusion-positive, BRAF V600E mutation, MET exon 14 skipping mutation, or other targetable alterations with approved therapies. 3. Prior treatments including: 1. Systemic anti-tumor therapy for advanced/metastatic NSCLC (e.g., chemotherapy/targeted/immunotherapy). Neoadjuvant/adjuvant therapy exceptions per Inclusion Criterion #6. 2. \>30 Gy thoracic radiotherapy within 6 months or non-thoracic radiotherapy within 4 weeks prior to first dose (brain radiotherapy exceptions per Inclusion Criterion #12). 3. Any prior EGFR-targeted therapy (including investigational EGFR-TKIs, mAbs, bispecific antibodies, etc.). 4. Strong CYP3A4 inhibitors within 7 days or inducers within 21 days prior to first dose. 5. Anticancer traditional Chinese medicines within 2 weeks prior to first dose. 6. Non-specific immunomodulators (e.g., interferon, IL-2, thymosin) within 2 weeks prior to first dose. 7. Major trauma/surgery within 4 weeks prior to treatment initiation. 4. Clinically significant gastrointestinal abnormalities, including: * Moderate/severe atrophic gastritis * GI obstruction/perforation * Chronic diarrhea/short bowel syndrome * Major upper GI surgery (e.g., gastrectomy) * Inflammatory bowel disease (Crohn's/ulcerative colitis) or active intestinal inflammation * Inability to swallow tablets 5. Uncontrolled systemic diseases. 6. Severe acute/chronic infections. 7. Interstitial lung disease (ILD)/non-infectious pneumonia: * History requiring clinical intervention * Current presence * Suspicious imaging findings unresolved at screening 8. Clinically significant cardiovascular dysfunction (active or history). 9. Tumor invasion of critical adjacent structures (heart/esophagus/SVC etc.) with high bleeding/fistula risk. Exceptions may be considered if investigator assesses minimal risk. 10. Pulmonary comorbidities causing severe impairment, including: 1. Baseline lung diseases (e.g., pulmonary embolism \[≤3 months\], severe asthma/COPD/restrictive disease) 2. Autoimmune/connective tissue disorders with pulmonary involvement (e.g., rheumatoid arthritis, sarcoidosis) 11. Residual toxicity \>Grade 1 (per NCI CTCAE v5.0) from prior anticancer therapy (except alopecia/neuropathy). 12. Concurrent malignancies except: * Cured localized skin cancers (BCC/SCC), superficial bladder cancer, cervical/breast DCIS, or papillary thyroid cancer * Other malignancies cured by radical therapy ≥3 years prior 13. Pregnancy/lactation or planned pregnancy within 6 months post-treatment. 14. Inability to comply with study procedures/follow-up. 15. Known hypersensitivity to furmonertinib or excipients. 16. History of allergic reactions to pemetrexed/cisplatin/carboplatin. 17. Other exclusionary per investigator judgment, including: * Alcohol/drug abuse * Severe comorbidities (including psychiatric) requiring treatment * Critical laboratory abnormalities * Social/familial factors compromising safety/data collection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ethics Committee of cancer hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, Beijing Municipality, 100021, China

    Contact Email: •••••@•••••

  • Shandong Tumor Hospital

    RECRUITING

    Shandong, Jinan, China

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