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Phase 2 Study of MORAb-202 in Previously Treated Metastatic NSCLC AC
EU CTIS ID: 2023-504112-15-00
What this study is testing
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
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Chile
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Chile; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.