Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 PositivePhase 2NCT07710612
A Phase 2 Study of ABSK043 Combined With Osimertinib
A Phase 2 study testing ABSK043 in combination with Osimertinib in people with Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive, run by Abbisko Therapeutics Co, Ltd at 7 sites in China.
Trial summary
This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive
- What is being tested?
- ABSK043 in combination with Osimertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 7 sitesChina
- Study dates
- 31 Aug 2026to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or above, male or female.
- Participants must understand and voluntarily participate in this study and must have been provided informed consent for study participation.
- NSNLC confirmed by tissue or cytological pathology. NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology.
- Diagnosed locally advanced or metastatic NSCLC
- Different requirements for specific cohort:
- Dose escalation and backfill cohorts:
Show all 17Show fewer
- 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.
- Participants must have received ≥2 prior lines of frontline systemic therapy.
- Documented or central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%).
- Documented genetic testing report confirms the presence of EGFR alteration(s) in tumor or plasma.
- Expansion cohort(s):
- Participants must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting for locally advanced or metastatic disease.
- Central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%).
- Documented genetic testing reports confirm the presence of EGFR
- Presence of at least one measurable tumor lesion
- ECOG score 0-1 at screening.
- The expected life expectancy after the first dose is >12 weeks.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Kejing Tang, Doctor, +8620-87755766, tangkejing@163.com
Kejing Tang, Doctor
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Jianying Zhou, Doctor, +86571-87236876, drzjy@163.com
Jianying Zhou, Doctor
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Yanbin Zhao, Doctor, +86451-86298000 ext. +8613904811741, zhaoyb_gcp@126.com
Yanbin Zhao, Doctor
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Shun Lu, Doctor, +8621-62821990 ext. +8613601813062, shunlu_shchest@sina.com
Shun Lu, Doctor
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Mingfang Zhao, Doctor, +8624-83282888 ext. +8613644055129, zhaomf618@126.com
Mingfang Zhao, Doctor
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Wei Guo, Doctor, +86351-4881611, guowei812@126.com
Wei Guo, Doctor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Xiaorong Dong, Doctor, +8627-85728022 ext. +8613986252286, xhzzdxr@126.com
Xiaorong Dong, Doctor
About this study
Official title: A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer
Read the detailed description
This is an open-label study with an escalation part and an expansion part. The dose escalation part will evaluate the safety, tolerability of ABSK043 in combination with Osimertinib in previously treated participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. The expansion part will evaluate the efficacy of ABSK043 in combination with Osimertinib as first-line treatment for participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC at the one or more recommended dose(s). The safety, tolerability, and PK profile of ABSK043 in combination with Osimertinib will also be further evaluated.
Escalation Part:
The escalation part includes dose escalation cohorts and backfill cohort(s), enrolling a sufficient number with previously treated participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC.
Expansion Part:
The expansion part will enroll a sufficient number with treatment-naïve participants with locally advanced or metastatic NSCLC harboring the EGFR mutation and PD-L1 positive expression.
- Being tested
- ABSK043 in combination with Osimertinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK043 in combination with OsimertinibDrug
Three potential dose levels of ABSK043 are prespecified, and Osimertinib will be administered orally at a fixed dose of 80 mg QD in escalation cohort.
Patients in dose confirmation cohort and dose expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity of the combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| ABSK043 in combination with Osimertinib | Experimental | This is an open-label phase 2 study with an escalation part and an expansion part. Receives: Drug: ABSK043 in combination with Osimertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Incidence of dose-limiting toxicity (DLT)
Escalation Part
Measured: At the end of Cycle 1 (each cycle is 21 days)
Adverse events(AEs)
Escalation Part
Measured: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.
Serious adverse events (SAEs)
Escalation Part
Measured: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.
Adverse events of special interest (AESIs)
Escalation Part
Measured: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.
Progression-free survival at 12 month
Expansion Part
Measured: From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.
Secondary outcomes (16)
Maximum observed concentration（Cmax）
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Area under the concentration-time curve area under the concentration-time curve area under the concentration-time curve (AUC)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Elimination half-life(t1/2)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Apparent volume of distribution(Vz/F)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Apparent oral clearance(CL/F)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Maximum observed concentration after multiple doses(Cmax,ss)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Minimum observed concentration after multiple doses(Cmin,ss)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Area under the concentration-time curve after multiple doses(AUCtau,ss)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Accumulation ratio(AR)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Time to maximum observed concentration(tmax)
Escalation Part
Measured: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Progression-Free Survival (PFS)
Escalation Part
Measured: From treatment start up to 5 years
Objective response rate (ORR)
Defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1.
Measured: From treatment start up to 5 years
Duration of response (DOR)
Defined as the time (months) from the first documented objective response to the investigator-assessed radiographic disease progression (PD) according to RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From treatment start up to 5 years
Disease control rate (DCR)
Defined as the proportion of participants achieving confirmed complete remission (CR) or partial remission (PR), or stable disease (SD), as assessed by the investigator according to RECIST v1.1.
Measured: From treatment start up to 5 years
Time to progression (TTP)
Defined as the time (months) from the first dose of study drug until the onset of radiographic disease progression (PD) as assessed by the investigator according to RECIST v1.1.
Measured: From treatment start up to 5 years
Overall survival (OS)
Defined as the time (months) from the first administration of study drug to death due to any cause.
Measured: From treatment start up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start31 Aug 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 PositiveStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710612
- Sponsor's protocol ID
- ABSK043-203
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Study to Evaluate the Efficacy and Safety of ABSK043 Combined With Osimertinib in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07710612
- Acronym / sponsor ID
- ABSK043-203
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 17 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer
Detailed description
This is an open-label study with an escalation part and an expansion part. The dose escalation part will evaluate the safety, tolerability of ABSK043 in combination with Osimertinib in previously treated participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. The expansion part will evaluate the efficacy of ABSK043 in combination with Osimertinib as first-line treatment for participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC at the one or more recommended dose(s). The safety, tolerability, and PK profile of ABSK043 in combination with Osimertinib will also be further evaluated.
Escalation Part:
The escalation part includes dose escalation cohorts and backfill cohort(s), enrolling a sufficient number with previously treated participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC.
Expansion Part:
The expansion part will enroll a sufficient number with treatment-naïve participants with locally advanced or metastatic NSCLC harboring the EGFR mutation and PD-L1 positive expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSK043 in combination with Osimertinib | Experimental | Drug: ABSK043 in combination with OsimertinibThis is an open-label phase 2 study with an escalation part and an expansion part. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Aged 18 or above, male or female.
- Participants must understand and voluntarily participate in this study and must have been provided informed consent for study participation.
- NSNLC confirmed by tissue or cytological pathology. NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology.
- Diagnosed locally advanced or metastatic NSCLC
- Different requirements for specific cohort:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK043 in combination with OsimertinibThree potential dose levels of ABSK043 are prespecified, and Osimertinib will be administered orally at a fixed dose of 80 mg QD in escalation cohort. Patients in dose confirmation cohort and dose expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity of the combination therapy. | Drug | ABSK043 in combination with Osimertinib |
Primary outcome
- Incidence of dose-limiting toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Escalation Part
Adverse events(AEs)
Time frame: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.
Escalation Part
Serious adverse events (SAEs)
Time frame: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.
Escalation Part
Adverse events of special interest (AESIs)
Time frame: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.
Escalation Part
Progression-free survival at 12 month
Time frame: From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.
Expansion Part
16 secondary outcomes
Maximum observed concentration（Cmax）
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Area under the concentration-time curve area under the concentration-time curve area under the concentration-time curve (AUC)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Elimination half-life(t1/2)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Apparent volume of distribution(Vz/F)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Apparent oral clearance(CL/F)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Maximum observed concentration after multiple doses(Cmax,ss)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Minimum observed concentration after multiple doses(Cmin,ss)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Area under the concentration-time curve after multiple doses(AUCtau,ss)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Accumulation ratio(AR)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Time to maximum observed concentration(tmax)
Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Progression-Free Survival (PFS)
Time frame: From treatment start up to 5 years
Objective response rate (ORR)
Time frame: From treatment start up to 5 years
Duration of response (DOR)
Time frame: From treatment start up to 5 years
Disease control rate (DCR)
Time frame: From treatment start up to 5 years
Time to progression (TTP)
Time frame: From treatment start up to 5 years
Overall survival (OS)
Time frame: From treatment start up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABSK043 in combination with Osimertinib in people with Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive, run by Abbisko Therapeutics Co, Ltd at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zan Chen (+8613816094024, zan.chen@abbisko.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Incidence of dose-limiting toxicity (DLT) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.