A clinical study of MK-2870 and chemotherapy to treat lung cancer (MK-2870-009)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

15 Jul 2024 → ongoing

Decision date (initial)

2024-06-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-504910-31-00

WHO UTN

U1111-1288-3804

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Pharmacogenomic, Pharmacogenetic, Therapy

1. To compare sacituzumab tirumotecan to platinum-based doublet chemotherapy with respect to PFS per RECIST 1.1 as assessed by BICR
2. To compare sacituzumab tirumotecan to platinum-based doublet chemotherapy with respect to OS

Secondary objectives 5

1. To compare sacituzumab tirumotecan to platinum-based doublet chemotherapy with respect to ORR per RECIST 1.1 as assessed by BICR
2. To evaluate the DOR of sacituzumab tirumotecan versus platinum-based doublet chemotherapy
3. To evaluate the mean change from baseline in global health status/QoL, dyspnea, cough, and chest pain for sacituzumab tirumotecan versus platinum-based doublet chemotherapy
4. To evaluate the time to deterioration in global health status/QoL, dyspnea, cough, and chest pain for sacituzumab tirumotecan versus platinum-based doublet chemotherapy
5. To evaluate the safety and tolerability of sacituzumab tirumotecan

Conditions and MedDRA coding

Non-small Cell Lung Cancer (NSCLC)

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
2. Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baseline.
3. Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
4. Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
5. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
6. Life expectancy of at least 3 months.

Exclusion criteria 16

1. Predominantly squamous cell histology NSCLC.
2. History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
3. Grade >2 peripheral neuropathy.
4. History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
5. Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
6. Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
7. Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
8. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
9. Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
10. Known active central nervous system metastases and/or carcinomatous meningitis.
11. Active infection requiring systemic therapy.
12. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
13. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
14. Concurrent active HBV and HCV infection.
15. History of allogeneic tissue/solid organ transplant.
16. Participants who have not adequately recovered from major surgery or have ongoing surgical complications.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Progression-free survival (PFS)
2. Overall survival (OS)

Secondary endpoints 12

1. Objective response rate (ORR)
2. Duration of response (DOR)
3. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) global health status (Item 29) and quality of life (Item 30) combined score
4. Change from baseline in the dyspnea (item 8) score, on the EORTC QLQ-C30
5. Change from baseline in the cough (item 31) score, on the EORTC Lung-Cancer specific Quality of Life Questionnaire (QLQ-LC13)
6. Change from baseline in the chest pain (item 40) score, on the EORTC QLQ-LC13
7. Time to deterioration (TTD) in global health status/quality of life (items 29 and 30) score, on the EORTC-QLQ-C30
8. TTD in the dyspnea (item 8) score, on the EORTC QLQ-C30
9. TTD in the cough (item 31) score, on the EORTC QLQ-LC13
10. TTD in the chest pain (item 40) score, on the EORTC QLQ-LC13
11. Number of participants who experience one or more adverse events (AEs)
12. Number of participants who discontinue study treatment due to an AE

Investigational products

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

Test 1

Comparator 2

Auxiliary 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Kumar Rajagopalan

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Kumar Rajagopalan

Third parties 7

Locations

5 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

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

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 2 · Art. 38 CTR

Results and documents

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

Documents 46 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