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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol Myers Squibb International Corporation

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

4 Jan 2023 → 13 Aug 2024

Decision date (initial)

2024-04-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2023-504112-15-00

EudraCT number

2022-000131-23

WHO UTN

U1111-1273-2077

ClinicalTrials.gov

NCT05577715

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Dose response, Safety, Pharmacokinetic, Pharmacodynamic, Pharmacogenomic

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 objectives 4

1. To evaluate progression-free survival (PFS) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
2. To evaluate progression-free survival (PFS) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
3. To evaluate disease control rate (DCR) of MORAb-202 in participants with previously treated, metastatic NSCLC AC
4. 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)

Conditions and MedDRA coding

Metastatic Non-Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

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 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
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 platinumbased 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 randomization.

Exclusion criteria 3

1. 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
2. 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
3. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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

Secondary endpoints 2

1. Incidence and severity of adverse events (AEs)/serious AEs (SAEs), treatment related AEs/SAEs, AEs of special interest (AESI), deaths and laboratory abnormalities.
2. PFS by RECIST 1.1 per investigator assessment

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol Myers Squibb International Corporation

Sponsor organisation

Bristol Myers Squibb International Corporation

Address

Terhulpsesteenweg 185

City

Watermaal-Bosvoorde

Postcode

1170

Country

Belgium

Scientific contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Public contact point

Organisation

Bristol Myers Squibb International Corporation

Contact name

GSM-CT

Third parties 3

Locations

2 EU/EEA countries · 11 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications