New drug combo aims to outsmart resistant lung cancer
NCT ID NCT07710612
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
7 sites. The list below names each one and where it is.
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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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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
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Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
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Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
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Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
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The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
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The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China