Metastatic Non-Small Cell Lung Cancer MedDRA version: 21.1 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Participants or legally acceptable representatives who signed Written Informed Consent 2) Participants (male or female) must be 18 years or older at the time of signing the informed consent 3) Participants with histologically or cytologically documented metastatic NSCLC adenocarcinoma (AC) 4) Investigator-assessed radiologically documented disease progression during or after last treatment 5) Measurable target disease assessed by the investigator according to RECIST 1.1. 6) Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of disease progression based on RECIST 1.1 to be deemed a target lesion. 7) ECOG PS of 0 or 1 8) Participants must have received prior treatment, including platinum based chemotherapy and: i) If without actionable genetic alterations or unknown genetic alterations status, treatment with anti-PD-1/PD-L1 OR ii) If with known actionable genetic alterations, treatment with at least 1 targeted therapy 9) Participants must have received no more than 3 prior lines of systemic therapy in the metastatic setting NOTE: Participants with resectable or stage 3 locally advanced disease that has recurred or progressed within 1 year from the start of treatment with platinum based chemotherapy and anti-PD-1/PD-L1 are not required to be retreated in the metastatic setting to be eligible. 10) 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 treatment assignment. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 18
Exclusion criteria
Exclusion criteria: Medical Conditions -NSCLC histologies other than adenocarcinoma (AC) -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 -Current infectious pneumonia (including COVID-19-related infection), history of viral pneumonia with evidence of persistent radiologic abnormalities -Investigator assessed current ILD/pneumonitis or ILD/pneumonitis is suspected at Screening or history of ILD/pneumonitis of any severity including ILD/pneumonitis from prior anticancer therapy -Participants with an active, known or suspected autoimmune disease, connective tissue, or inflammatory disorders with documented pulmonary involvement Prior/Concomitant Therapy -Participants who have received prior investigational treatment with FRa-targeting agent, or FRa-targeting ADCs including MORAb-202. -Any condition requiring folate supplementation (eg, folate deficiency). -Any major surgery within 4 weeks of the first dose of study treatment Physical and Laboratory Test Findings -Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs leading to discontinuation, AEs of special interest (AESI), deaths and laboratory abnormalities. Incidence of treatment-related adverse events (TRAEs) leading to study treatment discontinuation ;Timepoint(s) of evaluation of this end point: 30 days after last patient completed a maximum of 2 year study treatment or the date of discontinuation, whichever occurred first. ;Main Objective: 1. To assess safety and tolerability of MORAb-202 in participants with previously treated, metastatic non-small cell lung cancer (NSCLC) adenocarcinoma (AC) 2. To assess tumor response of MORAb-202 in participants with previously treated, metastatic NSCLC AC;Secondary Objective: 1. To evaluate progression-free survival (PFS) of MORAb-202 in participants with previously treated, metastatic NSCLC AC 2. To evaluate disease control rate (DCR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC 3. To evaluate duration of response (DoR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC who achieved a complete response (CR) or partial response (PR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs of special interest (AESI), deaths and laboratory abnormalities. -PFS by RECIST 1.1 per investigator assessment ;Timepoint(s) of evaluation of this end point: -30 days after last patient completed a maximum of 2 year study treatment or the date of discontinuation, whichever occurred first. -All participants have been followed up for a minimum of 6 months. | — |
Countries
Australia, Belgium, Chile, France, Spain, United States
Contacts
Public ContactHead of the GSM-CT
Bristol -Myers Squibb International Corporation
Outcome results
None listed