Can a new pill boost chemotherapy against Hard-to-Treat lung cancer?

NCT ID NCT07070440

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests an experimental oral drug called DZD6008, given together with standard chemotherapy, in people with advanced non-small cell lung cancer that has an EGFR mutation. The study includes patients whose cancer has progressed after earlier EGFR-targeted therapy, as well as those who have not yet received treatment. Researchers will measure safety, side effects, and how well the combination shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DZD6008, an experimental oral drug, combined with standard chemotherapy drugs (pemetrexed, carboplatin, or docetaxel)
What this could lead to
If it works, this combination could offer a new treatment option for people with advanced EGFR-mutant lung cancer whose current therapy has stopped working.
What could go wrong
This is an early-phase trial, so the drug may not prove safe or effective. Side effects from the combination are possible, and results may not apply to all patients.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 180 people

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

Started

Jul 2025

Expected to finish

Dec 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. Signed informed consent. 2. Age ≥18 years old. 3. Locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment. 4. Documentation of EGFR sensitizing mutation confirmed by local laboratory. 5. Provide sufficient tumor tissue samples and plasma samples for retrospective analysis of EGFR mutations by central laboratory. 6. Failure of prior 3 generations EGFR TKI or treatment naive. 7. ECOG status score 0-1, life expectancy ≥12 weeks. 8. No central nervous system symptoms during screening, no need for corticosteroids or dehydration diuretic treatment for at least 4 weeks before the first dosing. If the patient with brain metastasis has received radiotherapy or surgery, there is a washout period of ≥2 weeks before the first use of DZD6008 and ensure that the AE related to radiotherapy or surgery has recovered to ≤ 1 grade. 9. Presence of measurable lesions defined by RECIST 1.1. 10. Sufficient bone marrow or other organ reserve before first dosing. Exclusion criteria 1. Histology mixed with small cell lung cancer (SCLC) or with SCLC transformation. 2. Received the following treatments or had the following lifestyle habits, etc.: * Received immunotherapy or other antibody treatments (including EGFR-targeted antibodies, bispecific antibodies or antibody-drug conjugates, etc.) within 4 weeks before the first study drug administration. * Received any cytotoxic chemotherapy, study drugs or other anti-cancer drugs (excluding macromolecule drugs) within 14 days before the first study drug administration. * Received limited-range radiotherapy to relieve the disease within 7 days before the first study drug administration, or received more than 30% of the bone marrow radiotherapy or received wide-range radiotherapy within 28 days before the first medication. * 2 weeks (for CYP3A4 inhibitors) or 3 weeks (for CYP3A4 inducers) before the first study drug administration, are taking or cannot stop taking known cytochrome P450 (CYP) 3A4 strong inhibitors or inducers (including herbal supplements, such as St. John's wort). * 2 weeks before the first study drug administration, are taking or cannot stop taking known CYP3A4 sensitive substrate drugs (with a narrow therapeutic window). * Taking or being unable to stop taking drugs known to be proton pump inhibitors within 1 week before the first study drug administration. * Major invasive surgery has been performed within 4 weeks before the first study drug administration or is planned during treatment. 3. Presence of AEs of \>1 grade (except any degree of alopecia) caused by previous treatment (such as adjuvant chemotherapy, radiotherapy). 4. Tumor-related spinal cord compression or meningeal metastasis. 5. History of malignant tumor within 2 years (except for basal cell carcinoma of the skin or cervical cancer in situ that has been adequately treated; other tumors that have been tumor-free for more than 2 years and are expected to survive for more than 2 years, which needs to be discussed with Dizal clinical research physicians). 6. Presence of severe or uncontrollable systemic diseases, including poorly controlled hypertension, bleeding diseases. 7. Presence of persistent or active infections, including but not limited to hepatitis B, hepatitis C and human immunodeficiency virus infection (HIV). 8. Any of the following heart-related diseases or abnormalities: * QT interval (QTc) \>470 msec after calibration of 12-lead ECG at rest during the screening period. * Any serious abnormalities of heart rate, conduction or pattern shown on the ECG at rest, such as complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 msec. * Any disease or condition that can cause QTcF prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or family members with a history of sudden death under the age of 40. * Severe cardiovascular diseases such as myocardial infarction, unstable angina or congestive heart failure, cerebrovascular accident (such as history of stroke or intracranial hemorrhage) within 6 months before the first dose. * History of deep vein thrombosis or pulmonary embolism within 4 weeks before the first dose (excluding non-obstructive catheter-related thrombosis). 9. Patient history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid hormone treatment, or any clinically active ILD, immunotherapy-related pneumonitis. 10. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, or previous intestinal resection that prevents adequate absorption of study medication. 11. Live vaccine within 4 weeks before the first dose.

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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 places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Shanghai Chest Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, China

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