Not Yet RecruitingPhase 2

A Phase 2 Study of ABSK043 Combined With Osimertinib

China72 participantsStarted 2026-08-31

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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%).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

- Incidence of dose-limiting toxicity (DLT)

Timeframe: At the end of Cycle 1 (each cycle is 21 days)

Adverse events(AEs)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

Timeframe: From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.

Trial details

NCT IDNCT07710612

SponsorAbbisko Therapeutics Co, Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Zan Chen

+8613816094024 zan.chen@abbisko.com

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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:
. 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%).

What they're measuring

- Incidence of dose-limiting toxicity (DLT)

Timeframe: At the end of Cycle 1 (each cycle is 21 days)

Adverse events(AEs)

Timeframe: 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)

Timeframe: 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)

Timeframe: 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

Timeframe: From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.