Lung Cancer Clinical Trial

A Study of MORAb-202 in Participants With Previously Treated Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC)

Summary

The aim of this study is to characterize the safety and tolerability of MORAb-202, and to assess the objective response rate in participants with previously treated, metastatic NSCLC AC.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).

Participants without genetic alterations or unknown genetic alterations in the metastatic setting after receiving:

i) 1 prior line of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given concurrently or ii) 2 prior lines of therapy if platinum-doublet chemotherapy and anti-PD-1/PD-L1 were given sequentially.

Participants with known targetable genetic alterations in the metastatic setting after receiving:

i) At least 1 approved targeted therapy and ii) No more than 3 prior lines of systemic therapy (including no more than 1 line of chemotherapy).

Either FFPE tissue block (preferred), newly cut unstained slides or newly obtained biopsies must be available for assessment by IHC at a central laboratory prior to randomization.

Exclusion Criteria:

NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
Pulmonary function test (PFT) abnormalities: Forced expiratory volume during first second of forced breath (FEV1) < 70%, or forced vital capacity (FVC) < 60%, and diffusing capacity of the lung for carbon monoxide (DLCO) < 80%.
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.

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05577715

Recruitment Status:

Not yet recruiting

Sponsor:

Bristol-Myers Squibb

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There are 13 Locations for this study

See Locations Near You

Rocky Mountain Cancer Centers (Lone Tree) - USOR
Lone Tree Colorado, 80124, United States More Info
Robert Jotte, Site 0035
Contact
303-388-4876
Henry Ford Hospital
Detroit Michigan, 48202, United States More Info
Shirish Gadgeel, Site 0004
Contact
313-399-0508
Mayo Clinic- Rochester
Rochester Minnesota, 55905, United States More Info
Konstantinos Leventakos, Site 0042
Contact
Texas Oncology-Arlington North
Arlington Texas, 76012, United States More Info
John Adams, Site 0034
Contact
817-261-4906
Virginia Cancer Specialists, PC Fairfax
Fairfax Virginia, 22031, United States More Info
Alexander Spira, Site 0033
Contact
703-280-5390
Local Institution - 0032
Liverpool New South Wales, 1871, Australia More Info
Site 0032
Contact
Local Institution - 0040
Wollongong New South Wales, 2500, Australia More Info
Site 0040
Contact
Local Institution - 0036
Roeselare BL, 8800, Belgium More Info
Site 0036
Contact
Local Institution - 0030
Independencia Santiago, 83804, Chile More Info
Site 0030
Contact
Local Institution - 0037
Paris , 75248, France More Info
Site 0037
Contact
Local Institution - 0029
Saint Herblain , 44805, France More Info
Site 0029
Contact
Local Institution - 0038
Villejuif , 94805, France More Info
Site 0038
Contact
Local Institution - 0031
Sevilla , 41013, Spain More Info
Site 0031
Contact

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05577715

Recruitment Status:

Not yet recruiting

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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