18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate as Per InvestigatorPrimary· From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
ORR is defined as the percentage of participants whose best overall response (BOR) is either CR or PR per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions
Group
Value
95% CI
MORAb-202 25mg/m^2
9.7
2.0 – 25.8
Number of Participants With Drug -Related Adverse Events Leading to DiscontinuationPrimary· From first dose and 30 days after last dose of study therapy (up to approximately 12 months).
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Group
Value
95% CI
MORAb-202 25mg/m^2
3
Number of Participants With Adverse Events and Serious Adverse Events and Adverse Event of Special Interest (AESI) and Deaths and Grade 3/4 Laboratory Abnormalities (SI Units)Secondary· From first dose and 30 days after last dose of study therapy (up to approximately 12 months).
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment. Serious adverse events (SAE) are defined as any AE which results in death; is life-threatening; req
Adverse Events Grade 1
Group
Value
95% CI
MORAb-202 25mg/m^2
10
Adverse Events Grade 2
Group
Value
95% CI
MORAb-202 25mg/m^2
5
Adverse Events Grade 3
Group
Value
95% CI
MORAb-202 25mg/m^2
3
Adverse Events Grade 4
Group
Value
95% CI
MORAb-202 25mg/m^2
0
Adverse Events Grade 5
Group
Value
95% CI
MORAb-202 25mg/m^2
0
Serious Adverse Events (Any Grade)
Group
Value
95% CI
MORAb-202 25mg/m^2
7
Serious Adverse Events (Grade 3/4)
Group
Value
95% CI
MORAb-202 25mg/m^2
7
Serious Adverse Events Grade 5
Group
Value
95% CI
MORAb-202 25mg/m^2
1
Disease Control Rate as Per InvestigatorSecondary· From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
Disease Control Rate (DCR) is defined as the number of randomized participants who achieve a BOR of confirmed CR, confirmed PR, or stable disease (SD) divided by the number of all randomized participants. per response evaluation criteria in solid tumors (RECIST) v1.1 based on Clopper-Pearson method.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm.
Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum
Group
Value
95% CI
MORAb-202 25mg/m^2
67.7
48.6 – 83.3
Duration of Response as Per InvestigatorSecondary· From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
DOR for a participant with a best overall response (BOR) of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression by investigator per response evaluation criteria in solid tumors (RECIST) v1.1 or death, whichever occurs first.
CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\\< 10 mm.
PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
PD: At least a 20% in
Group
Value
95% CI
MORAb-202 25mg/m^2
NA
NA – NA
Progression Free-Survival as Per InvestigatorSecondary· From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)
PFS is defined for all randomized participants as the date from randomization to the date of the documentation of disease progression or death due to any cause, whichever is earlier.
Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.
Group
Value
95% CI
MORAb-202 25mg/m^2
3.52
2.60 – 5.42
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, serious and non-serious adverse events were collected from first dose until 30 days after last dose (Up to approximately 12 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
MORAb-202 25mg/m^2
Serious: 7/31 (23%)
Deaths: 7/31
Serious adverse events (11 terms)
Reaction
System
MORAb-202 25mg/m^2
Hip fracture
Injury, poisoning and procedural complications
—
Rib fracture
Injury, poisoning and procedural complications
—
Blood creatinine increased
Investigations
—
Neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 4 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05577715.