A Phase 2 study of JNJ-90301900 with chemoradiation and durvalumab for non-small cell lung cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Johnson & Johnson Enterprise Innovation Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Aug 2025 → ongoing

Decision date (initial)

2025-03-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Johnson & Johnson Enterprise Innovation, Inc

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Dose response, Pharmacokinetic, Safety

To determine whether JNJ-90301900 as a radioenhancer added to cCRT followed by cIT can improve objective response rate (ORR) in participants with locally advanced and unresectable Stage III NSCLC

Conditions and MedDRA coding

Locally advanced and unresectable Stage III non-small cell lung cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Have locally advanced and unresectable stage III lung cancer
2. Pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization. Pathologic mediastinal staging with mediastinoscopy, mediastinotomy, EBUS, EUS, and/or CT guided biopsy is required when deemed technically feasible and clinically appropriate.
3. A candidate for standard of care treatment of study cancer by cCRT followed by consolidation durvalumab treatment
4. Have at least one target lesion (primary lung lesion or involved lymph nodes) planned to receive the full dose of prescribed RT [60 Gy]) per RECIST 1.1 that is amenable to intratumoral or intranodal injection and external-beam irradiation and IMRT as determined by the investigator at screening.
5. Have documented tumor proportion score (TPS) of PD-L1 by local or central lab
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
7. Life expectancy ≥6 months at Consent

Exclusion criteria 4

1. Have mixed small cell and non-small cell lung cancer histology
2. Prior systemic ChT for lung cancer within the prior 36 months at informed consent
3. Participant received prior intrathoracic RT that would overlap with the current study PTV for lung cancer, or recommended normal tissue constraints are exceeded when creating a summation of the prior and current radiation plans. Prior RT is allowable only if the treatment is >36 months at informed consent and does not interfere with the study lesion assessment; RT to chest wall, such as for early-stage breast cancer or skin cancer, is allowable
4. Contraindications to the use of JNJ-90301900 per the IB or platinum-based doublet ChT or durvalumab per local prescribing information

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ORR using Independent Central Review (ICR) assessments according to RECIST v1.1 (best response)

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Johnson & Johnson Enterprise Innovation Inc.

Sponsor organisation

Johnson & Johnson Enterprise Innovation Inc.

Address

1 Johnson And Johnson Plaza

City

New Brunswick

Postcode

08933-0001

Country

United States

Scientific contact point

Organisation

Johnson & Johnson Enterprise Innovation Inc.

Contact name

CTIS Point of Contact

Public contact point

Organisation

Johnson & Johnson Enterprise Innovation Inc.

Contact name

CTIS Point of Contact

Third parties 4

Locations

3 EU/EEA countries · 12 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 25 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