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A Phase 2 Study of ABSK043 Combined With Osimertinib

ConditionNon-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbbisko Therapeutics Co, Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

1. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

72 Participants
are divided into 1 treatment group
Group A: ABSK043 in combination with OsimertinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

- Incidence of dose-limiting toxicity (DLT)

Escalation Part

Time frame
At the end of Cycle 1 (each cycle is 21 days)
2

Adverse events(AEs)

Escalation Part

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.
3

Serious adverse events (SAEs)

Escalation Part

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.
4

Adverse events of special interest (AESIs)

Escalation Part

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.

Secondary outcomes

1

Maximum observed concentration（Cmax）

Escalation Part

Time frame
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
2

Area under the concentration-time curve area under the concentration-time curve area under the concentration-time curve (AUC)

Escalation Part

Time frame
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
3

Elimination half-life(t1/2)

Escalation Part

Time frame
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
4

Apparent volume of distribution(Vz/F)

Escalation Part

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Abbisko Therapeutics Co, Ltd

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: