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A Study to Assess The Safety and Tolerability of Pumitamig-Based Therapy Administered Before Surgery in Participants With Early-Stage Non-Small Cell Lung Cancer (ROSETTA Lung-220)

ConditionEarly-Stage Non-Small Cell Lung Cancer
Trial statusNot yet recruiting
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 surgical feasibility of preoperative Pumitamig-based therapy and other molecules in resectable, Early-Stage Non-Small Cell Lung Cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have newly diagnosed, previously untreated participants with histologically confirmed non-small cell lung cancer (NSCLC) (squamous or non-squamous histology); resectable Stage IIA to IIIB (N2) disease (American Joint Committee on Cancer (AJCC) 9th edition).

Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Participants must have an evaluable programmed death-ligand 1 (PD-L1) expression.

Disqualifiers

Participants must not have unresectable disease, N3 nodal involvement, or any evidence of distant metastatic disease (M1) at baseline assessment (suspected or confirmed).

Participants must not have active, known autoimmune disease.

Participants must not have significant cardiovascular impairment as evidenced by uncontrolled hypertension (despite optimal medical treatment), congestive heart failure, active coronary disease (within 6 months prior to randomization), ventricular arrhythmias or major thrombotic or embolic events.

Participants must not have advanced/clinically significant lung disease (within 6 months prior to randomization) or history of interstitial lung disease (ILD) or pneumonitis requiring treatment with systemic steroids (≥ Grade 2), or who have current or suspected ILD or pneumonitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pumitamig

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

  • Paclitaxel

    Drug

    Specified dose on specified days

  • Pemetrexed

    Drug

    Specified dose on specified days

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort A: PumitamigExperimental treatment 5 interventions
Group B: Cohort B: PumitamigExperimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Achievement of pathologic complete response (pCR) by blinded independent pathology review (BIPR)

Time frame
Up to 6 weeks after last dose

Secondary outcomes

1

Incidence of all-causality

Time frame
Up to 5 years from safety follow-up
2

Number of participants with treatment-related adverse events (TRAEs)

Time frame
Up to 90 days after surgery
3

Number of participants with serious adverse events (SAEs)

Time frame
Up to 90 days after surgery
4

Number of participants with immune related adverse events (irAEs)

Time frame
Up to 90 days after surgery

Other outcomes

Sponsors and contacts

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

Bristol-Myers Squibb

Lead sponsor

BioNTech SE

Collaborator

Source ClinicalTrials.gov

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