New drug combo aims to outsmart resistant lung cancer

NCT ID NCT07710612

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This phase 2 trial tests whether adding an experimental drug called ABSK043 to the standard targeted therapy osimertinib can help people with a specific type of advanced lung cancer (EGFR-mutated, PD-L1 positive). The study enrolls adults whose cancer has spread or cannot be surgically removed. Researchers will monitor safety, side effects, and how long the cancer stays under control.

What this could mean

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

Active substance
ABSK043 combined with osimertinib
What this could lead to
If successful, this combination could offer a new treatment option for people with EGFR-mutated lung cancer that has stopped responding to standard therapy.
What could go wrong
This is an early-phase trial with a small number of participants, so the benefits and risks are not yet fully known. The combination may cause side effects or fail to improve outcomes.

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

About 72 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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. Aged 18 or above, male or female. 2. Participants must understand and voluntarily participate in this study and must have been provided informed consent for study participation. 3. NSNLC confirmed by tissue or cytological pathology. NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology. 4. Diagnosed locally advanced or metastatic NSCLC 5. Different requirements for specific cohort: Dose escalation and backfill cohorts: 1. Participants with disease in the adjuvant setting, post chemoradiotherapy setting, locally advanced stage or metastatic stage, who have received at least one prior line of third-generation EGFR-TKI-based monotherapy or combination therapy and experienced disease progression. 2. Participants must have received ≥2 prior lines of frontline systemic therapy. 3. Documented or central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%). 4. Documented genetic testing report confirms the presence of EGFR alteration(s) in tumor or plasma. Expansion cohort(s): 1. Participants must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting for locally advanced or metastatic disease. 2. Central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%). 3. Documented genetic testing reports confirm the presence of EGFR 6. Presence of at least one measurable tumor lesion 7. ECOG score 0-1 at screening. 8. The expected life expectancy after the first dose is \>12 weeks. Exclusion Criteria: * 1\. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc. 2\. Has a history of interstitial lung disease (ILD)/pneumonitis or active ILD 3. Spinal cord compression and unstable brain metastases. 4.Any unresolved toxicities from prior systemic therapy greater than CTCAE v6.0 Grade 1 at the time of starting study treatment. 5\. Participants with obvious and unstable pleural effusion, peritoneal effusion or pericardial effusion . 6\. Has a history of other malignant tumors, or currently have other malignant tumors. 7\. Participants with known HIV infection.

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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

    7 sites. 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

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, China

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013, China

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China