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A Study To Assess the Safety, Tolerability, and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

ConditionsLocally Advanced Non-Small Cell Lung Cancer (NSCLC)Metastatic Non-Small Cell Lung Cancer (NSCLC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition.

Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.

Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site.

Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Disqualifiers

Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated.

Participants must not have prior treatment with immuno-oncology therapies.

Participants must not have untreated central nervous system (CNS) metastases.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pumitamig

    Drug

    Specified dose on specified days

  • Imzokitug

    Drug

    Specified dose on specified days

  • Pemetrexed

    Drug

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Paclitaxel

    Drug

    Specified dose on specified days

Treatment groups

160 Participants
are divided into 4 treatment groups
Group A: Arm A: Pumitamig + Imzokitug + Histology-based PDCTExperimental treatment 6 interventions
Group B: Arm B: Pumitamig + Imzokitug + Histology-based PDCTExperimental treatment 6 interventions
Group C: Arm C: Pumitamig + Imzokitug + Histology-based PDCTExperimental treatment 6 interventions
Group D: Arm D: Pumitamig + Histology-based PDCTExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)

Time frame
Up to approximately 4 years

Secondary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 90 days after discontinuation of study treatment
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to 90 days after discontinuation of study treatment
3

Number of participants with treatment-related AEs

Time frame
Up to 90 days after discontinuation of study treatment
4

Number of participants with treatment-related SAEs

Time frame
Up to 90 days after discontinuation of study treatment

Other outcomes

Sponsors and contacts

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

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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