Phase 2 Study of MORAb-202 in Previously Treated Metastatic NSCLC AC

Prior treatment

• Medical Conditions -NSCLC histologies other than adenocarcinoma (AC) -Not applicable per Protocol Amendment 2 : Pulmonary Function Test (PFT) abnormalities -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 FRα-targeting agent, or FRα-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

Lab values

• 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.

• Participants or legally acceptable representatives who signed Written Informed Consent
• 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.
• Participants (male or female) must be 18 years or older at the time of signing the informed consent
• Participants with histologically or cytologically documented metastatic NSCLC adenocarcinoma (AC)
• Investigator-assessed radiologically documented disease progression during or after last treatment
• Measurable target disease assessed by the investigator according to RECIST 1.1.
• 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
• ECOG PS of 0 or 1
• Participants must have received prior treatment, including platinumbased 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
• 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 platinumbased chemotherapy and anti-PD-1/PD-L1 are not required to be retreated in the metastatic setting to be eligible.