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Carcinoma, Non-Small-Cell LungPhase 2NCT05577715

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

A Phase 2 study testing MORAb-202 in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 33 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Non-Small-Cell Lung
What is being tested?
MORAb-202
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
33 sitesin 6 countries
Study dates
14 Nov 2022to 12 Aug 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically documented metastatic NSCLC AC (as defined by the 8th International Association for the Study of Lung Cancer Classification).
  • Measurable target disease assessed by the investigator according to RECIST 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1

Who cannot join

  • NSCLC histologies other than AC (ie, squamous cell carcinoma, large cell carcinoma).
  • 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.

Trial locations and contacts

33 sites in 6 countries.

33 sites in 6 countries

United States13 sites

  • Local Institution - 0034

    Arlington, Texas, 76012-2510

  • Local Institution - 0011

    Charlotte, North Carolina, 28207

  • Local Institution - 0043

    Clermont, Florida, 34711-6699

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2608

  • Local Institution - 0033

    Fairfax, Virginia, 22031-4629

  • Local Institution - 0045

    Flower Mound, Texas, 75028-1713

  • Local Institution - 0002

    Kansas City, Missouri, 64132

  • Local Institution - 0035

    Lone Tree, Colorado, 80124

  • Local Institution - 0005

    Louisville, Kentucky, 40241-2832

  • Local Institution - 0001

    Marietta, Georgia, 30060

  • Local Institution - 0007

    Orange, California, 92868-3201

  • Local Institution - 0010

    Orange City, Florida, 32763-8316

  • Local Institution - 0044

    Silver Spring, Maryland, 20904-7917

Other trials in United States

Spain7 sites

  • Local Institution - 0025

    Barcelona, 08035

  • Local Institution - 0021

    Barcelona, 08036

  • Local Institution - 0018

    Madrid, 28041

  • Local Institution - 0019

    Majadahonda (Madrid), M, 28222

  • Local Institution - 0020

    Málaga, MA, 29010

  • Local Institution - 0026

    Santiago de Compostela, 15706

  • Local Institution - 0031

    Seville, 41013

Other trials in Spain

Chile4 sites

  • Local Institution - 0030

    Independencia, 8380456

  • Local Institution - 0028

    Providencia, SA, 7500653

  • Local Institution - 0027

    Recoleta, 8420383

  • Local Institution - 0023

    Santiago, 7500921

Other trials in Chile

France4 sites

  • Local Institution - 0017

    Rouen, 76000

  • Local Institution - 0015

    Suresnes, 92151

  • Local Institution - 0014

    Toulon, 83056

  • Local Institution - 0038

    Villejuif, 94805

Other trials in France

Australia3 sites

  • Local Institution - 0012

    Ballarat Central, Victoria, 3350

  • Local Institution - 0022

    Murdoch, Western Australia, 6150

  • Local Institution - 0040

    Wollongong, NS, 2500

Other trials in Australia

Belgium2 sites

  • Local Institution - 0039

    Mons, WHT, 7000

  • Local Institution - 0036

    Roeselare, 8800

Other trials in Belgium

About this study

Official title: A Phase 2, Open-label, Randomized Study of MORAb-202 (Farletuzumab Ecteribulin), a Folate Receptor Alpha-targeting Antibody-Drug Conjugate, in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) Adenocarcinoma (AC) After Progression on Prior Therapies

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.

Being tested
MORAb-202
Keywords
NSCLC, MORAb-202, Farletuzumab ecteribulin, Adenocarcinoma
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MORAb-202Drug

    Also called Farletuzumab Ecteribulin, BMS-986445

    Specified dose on specified days

Study groups in NCT05577715
Study groupRoleWhat they receive
MORAb-202ExperimentalNot described
Receives: Drug: MORAb-202

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate as Per Investigator

    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, taking as reference the smallest sum during the 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.

    Measured: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

  2. Number of Participants With Drug -Related Adverse Events Leading to Discontinuation

    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.

    Measured: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).

Secondary outcomes (4)

  1. 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)

    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; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Death).

    Measured: From first dose and 30 days after last dose of study therapy (up to approximately 12 months).

  2. Disease Control Rate as Per Investigator

    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 diameters.

    Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

    Measured: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

  3. Duration of Response as Per Investigator

    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% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the 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.

    Measured: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

  4. Progression Free-Survival as Per Investigator

    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.

    Measured: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2022
  2. Study start14 Nov 2022
  3. Primary completion12 Aug 2024
  4. Study completion12 Aug 2024

Why it stopped: Business objectives have changed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05577715
Sponsor's protocol ID
CA116-003
Other IDs
2022-000131-23, MORAb-202-G000-203
Status last verified
Sep 2025
First submitted
10 Oct 2022
Last updated
4 Sep 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MORAb-202 in people with Carcinoma, Non-Small-Cell Lung, run by Bristol-Myers Squibb at 33 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Spain, Chile, France, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate as Per Investigator (time frame: From the date of randomization to the date of first objectively documented progression or death, whichever occurs first (Up to approximately 12 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05577715.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.

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