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RecruitingLast updated: 22 November 2023

CA116-003: This phase II study is assessing how safe and effective new targeted therapy (MORAb-202) is in people with previously treated, metastatic non-small cell lung cancer adenocarcinomaA Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

Clinical summary

Summary

Eligible participants will be randomly allocated to receive MORAb-202 at either Dose Level 1 or Dose Level 2.

Conditions

This trial is treating patients with non-small cell lung cancer adenocarcinoma

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

CA116-003

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

Eligibility

Inclusion

  • Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
  • Measurable target disease assessed by the investigator according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Exclusion

  • NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
  • Significant third-space fluid retention (eg, ascites or pleural effusion) that requires repeated drainage.
  • Prior pneumonectomy. Prior lobectomy and segmentectomy are allowed > 12 months before treatment.
  • Recent chest radiotherapy. Participants with chest or chest wall radiation may be permitted if chest radiation is documented > 6 months before starting study treatment.

Other protocol-defined inclusion/exclusion criteria apply.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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