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A Study of Ivonescimab in Combination With Dato-DXd or Osimertinib in People With Non-Small Cell Lung Cancer

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The researchers are doing this study to find out whether ivonescimab in combination with datopotamab deruxtecan- (Dato-DXd) or osimertinib are safe and effective treatments in people with non-small cell lung cancer (NSCLC) that has an EGFR mutation. The researchers will test different doses of the Dato-DXd or osimertinib with an unchanging (fixed) dose of ivonescimab to find the best dose that causes few or mild side effects in participants. Once the dose is found the researchers will test ivonescimab with Dato-DXd or osimertinib in a new group of participants to see if it is effective in treating their NSCLC with an EGFR mutation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent by participant

Biopsy-proven metastatic non-small cell lung cancer

Somatic activating mutation in EGFR in pre-treatment tumor biopsy or cfDNA (including all mutations with sensitivity to osimertinib) by any CLIA certified assay.

Prior treatment with 3rd-generation EGFR TKI therapy and platinum-based chemotherapy (or ineligible for platinum-based chemotherapy)

Disqualifiers

EGFR exon 20 insertion positive lung cancer with expected lack of sensitivity to osimertinib (Study Cohort B only).

Pregnant or lactating women

Participation in another clinical study and receiving treatment with an investigation product during the last 4 weeks before enrollment

Prior exposure to anti-PD-1 inhibitor therapy

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ivonescimab

    Drug

    20 mg/kg

  • Dato-DXd

    Drug

    dose escalation 4 mg/kg 6 mg/kg

  • Osimertinib

    Drug

    dose escalation 40mg 80 mg

Treatment groups

66 Participants
are divided into 4 treatment groups
Group A: Cohort A (ivonescimab + Dato-DXd) Phase IAExperimental treatment 2 interventions
Group B: Cohort B (Ivonescimab + Osimertinib) Phase IBExperimental treatment 2 interventions
Group C: Cohort A (ivonescimab + Dato-DXd) (Phase II)Experimental treatment 2 interventions
Group D: Cohort B (Ivonescimab + Osimertinib) (Phase II)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

determine the maximum tolerated dose (MTD) (phase I)

Three participants will be enrolled at starting dose level and assessed for dose limiting toxicities (DLTs) for 1 full cycle (21 days) in cohort A and 2 full cycles (42 days) for cohort B. Toxicity will be graded according to NCI CTCAE version 5.

Time frame
1 year
2

progression free survival (phase I)

defined as the proportion of patients who remained alive and progression-free at 6 months) will be computed by Kaplan-Meier estimates and reduced to a standard sample proportion in the absence of censoring, with the follow-up starting at the initiation of therapy.

Time frame
6 months
3

measure objective response rate (ORR) (phase II)

by RECIST v1.1

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Memorial Sloan Kettering Cancer Center

Lead sponsor

Summit Therapeutics

Collaborator

Source ClinicalTrials.gov
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