Can a daily pill outsmart resistant lung cancer mutations?

NCT ID NCT05559645

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests an experimental daily pill, DZD9008, in adults with advanced non-small cell lung cancer whose tumors carry certain EGFR mutations. Some participants have already tried standard treatments and their cancer progressed, while others are new to treatment. Researchers measure how long the drug keeps cancer from growing and how well it shrinks tumors, while also tracking safety and side effects.

What this could mean

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

Active substance
DZD9008, an experimental oral drug taken daily that targets cancer cells with certain EGFR mutations
What this could lead to
If it works, DZD9008 could offer a new treatment option for people with advanced lung cancer whose tumors carry specific EGFR mutations, especially those that no longer respond to standard therapies.
What could go wrong
This is an early-stage study, so the drug may not shrink tumors or improve survival in all patients. Side effects are possible, and results may not apply to everyone with lung cancer.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 180 people

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

Started

Nov 2021

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. To provide a signed and dated, written informed consent. 2. Aged ≥ 18 years old 3. Histologically or cytologically confirmed locally advanced or metastatic NSCLC with documented EGFR mutations from a local laboratory 4. ECOG performance status 0-1. 5. Predicted life expectancy ≥ 12 weeks 6. Patient must have measurable disease according to RECIST 1.1. 7. Patient who has progressed or intolerant to standard therapy (except treatment naïve patients in Cohort 4 and Cohort 7: with EGFR Exon20ins; in Cohort 5 with EGFR sensitizing mutation; and in Cohort8 with EGFR PACC mutation). 8. Patients with brain metastasis (BM) can be enrolled under the condition that BM is stable, neurologically asymptomatic and does not require corticosteroid treatment. 9. Adequate organ system function. * Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L * Platelets ≥ 100 x 10\^9/L * Hemoglobin ≥ 9 g/dL * Total bilirubin ≤ 1.5 x ULN if no liver metastases or ≤ 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN if no liver metastases or ≤ 5 x ULN with liver metastases * Creatinine ≤ 1.5 x ULN, concurrent with calculated or measured creatinine clearance ≥ 50 mL/min as calculated by the Cockcroft-Gault method or ≥ 50 mL/min in 24 hours * International normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN; * Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN Exclusion criteria: 1. Known history of bleeding diathesis. 2. Prior malignancy within 2 years requires active treatment. 3. Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of first administration. 4. History of stroke or intracranial haemorrhage within 6 months before the first administration. 5. Spinal cord compression or leptomeningeal metastasis. 6. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, which would jeopardize compliance with the protocol, or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 7. Any of the following cardiac criteria: * Mean resting corrected QT interval (QTcF) \> 470 msec obtained from 3 electrocardiograms (ECGs); * Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g., complete left bundle branch block, third degree heart block, and second-degree heart block, PR interval \> 250 msec. * Any factors that increase the risk of QTcF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval. * Prior history of atrial fibrillation within 6 months of first administration of DZD9008, except prior drug treatment related and recovered. 8. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease. 9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of DZD9008. 10. History of hypersensitivity to active or inactive excipients of DZD9008 or drugs with a similar chemical structure or class to DZD9008. 11. Women who are pregnant or breast feeding. 12. Involvement in the planning and conduct of the study. 13. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.

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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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100730, China

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