Study to assess the efficacy and safety of Rina-S in participants with non-small cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genmab A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

19 May 2026 → ongoing

Decision date (initial)

2026-04-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Genmab A/S

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Pharmacodynamic, Therapy

Assess anti-tumor activity of Rina-S monotherapy

Secondary objectives 4

1. 1. Assess additional measures of clinical efficacy, including antitumor activity and durability of response of Rina-S monotherapy
2. 2. Assess the pharmacokinetics (PK) of Rina-S monotherapy
3. 3. Assess the immunogenic potential of Rina-S monotherapy
4. 4. Assess the safety and tolerability of Rina-S monotherapy

Conditions and MedDRA coding

Locally advanced or metastatic Non-Small Cell Lung Cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
2. Participant must have radiological disease progression while on or after receiving the most recent regimen.
3. Participants either may have actionable genetic alterations (AGAs) or no AGAs.
4. Participant has measurable disease according to RECIST v1.1.
5. Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.

Exclusion criteria 3

1. Participant has NSCLC with histology other than adenocarcinoma
2. Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5- year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
3. Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [Time Frame: Approximately 3 years]

Secondary endpoints 8

1. 1.Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years]
2. 2.Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator [Time Frame: Approximately 4 years]
3. 3.Progression-free Survival (PFS) [Time Frame: Approximately 4 years]
4. 4.Overall Survival (OS) [Time Frame: Approximately 4 years]
5. 5.Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes [Time Frame: Approximately 12 months]
6. 6.Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes[Time Frame: Approximately 12 months]
7. 7.Number of Participants with Antidrug Antibodies (ADAs) [Time Frame: Approximately 12 months]
8. 8.Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Approximately 4 years]

Investigational products

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

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genmab A/S

Sponsor organisation

Genmab A/S

Address

Carl Jacobsens Vej 30

City

Valby

Postcode

2500

Country

Denmark

Scientific contact point

Organisation

Genmab A/S

Contact name

Genmab Trial Information

Public contact point

Organisation

Genmab A/S

Contact name

Genmab Trial Information

Third parties 5

Locations

8 EU/EEA countries · 52 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

Documents 73 files

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

Application history

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