A Phase 2 Study of ABSK043 Combined With Osimertinib

NCT07710612 | Not Yet Recruiting Phase 2

• 1 other identifier: ABSK043-203
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive

Outcome Measures

Primary Outcomes (5)

• - Incidence of dose-limiting toxicity (DLT)

  Escalation Part

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

• Adverse events(AEs)

  Escalation Part

  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

  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

  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

  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）

  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)

  From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.

• Elimination half-life(t1/2)

  From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.

• Apparent volume of distribution(Vz/F)

  From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.

• Apparent oral clearance(CL/F)

  From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.

Study Arms (1)

ABSK043 in combination with Osimertinib

EXPERIMENTAL

This is an open-label phase 2 study with an escalation part and an expansion part.

Drug: ABSK043 in combination with Osimertinib

Interventions

ABSK043 in combination with Osimertinib DRUG

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.

ABSK043 in combination with Osimertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• \. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.
• \. 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.
• \. Participants with obvious and unstable pleural effusion, peritoneal effusion or pericardial effusion .
• \. Has a history of other malignant tumors, or currently have other malignant tumors.
• \. Participants with known HIV infection.

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead
• AstraZeneca: collaborator

Study Sites (7)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

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

Wuhan, Hubei, 430022, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

MeSH Terms

Interventions

osimertinib

Central Study Contacts

Zan Chen

CONTACT

+8613816094024; zan.chen@abbisko.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (7)