A Phase 2 Study of ABSK043 Combined With Osimertinib

ClinicalTrials.gov ID

NCT07710612

Lead Sponsor

Abbisko Therapeutics Co, LtdINDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

72Estimated

Last Update Posted

Jul 17, 2026Actual

Start Date

Aug 31, 2026Estimated

Primary Completion Date

Dec 31, 2029Estimated

Completion Date

Dec 31, 2030Estimated

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

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

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.

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

• ABSK043 in combination with Osimertinib

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Abbisko Therapeutics Co, LtdINDUSTRY

Collaborators

AstraZenecaINDUSTRY

zhaoyb_gcp@126.com+86451-86298000 ext. +8613904811741

zhaomf618@126.com+8624-83282888 ext. +8613644055129

shunlu_shchest@sina.com+8621-62821990 ext. +8613601813062

guowei812@126.com+86351-4881611

drzjy@163.com+86571-87236876

• A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib

  NCT06668103

  RecruitingInterventionalPhase 2Updated Dec 12, 2024
• A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib

  NCT07164170

  RecruitingInterventionalPhase 2Updated Jun 17, 2026
• A Phase 2 Clinical Study of ABSK061 and ABSK043

  NCT06632262

  RecruitingInterventionalPhase 2Updated Nov 19, 2024
• BBP-398 in Combination With Osimertinib in Locally Advanced or Metastatic NSCLC Patients With EGFR Mutations

  NCT06032936

  TerminatedInterventionalPhase 1Updated Jun 25, 2024
• A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer

  NCT06225804

  RecruitingInterventionalPhase 1Updated Mar 18, 2024
• Advanced Lung Tumor Treated by Osimertinib Plus Anlotinib

  NCT04770688

  CompletedInterventionalPhase 1Phase 2Updated Aug 15, 2024