ClinicalTrials.gg
RecruitingNCT06667908CONVERGEUpdated Nov 3, 2026

A Study of JNJ-90301900 in Combination With Chemoradiation Followed by Consolidation Immunotherapy for Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 interventional study of JNJ-90301900 and Durvalumab in Carcinoma, Non-Small-Cell Lung, sponsored by Johnson & Johnson Enterprise Innovation Inc.. Recruiting at 45 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Johnson & Johnson Enterprise Innovation Inc. (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 11 months later.
Updated Nov 3, 2026Site recruiting status changed2 sites addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether JNJ-90301900 added to concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation immunotherapy (cIT) can improve objective response rate (ORR; that is percentage of participants whose best response is complete response or partial response during the study) in participants with locally advanced and unresectable stage III non-small cell lung cancer.

02

Conditions studied

  • Carcinoma, Non-Small-Cell Lung
03

In context

Carcinoma, Non-Small-Cell Lung

7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.

This study's planned enrollment of 130 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Johnson & Johnson Enterprise Innovation Inc. is the lead sponsor of 7 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be a candidate for standard of care (SOC) treatment of non small cell lung cancer (NSCLC) by concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) followed by consolidation durvalumab treatment as determined by the investigator and per local guidelines at screening
  • Have a medical history of pathologically (histologically or cytologically) proven diagnosis of NSCLC within 3 months prior to enrollment/randomization
  • Have locally advanced unresectable stage III NSCLC according to the eighth edition lung cancer stage classification
  • Have at least 1 target lesion (primary lung lesion or involved lymph node[s]) per version 1.1 that is amenable to intratumoral and/or intranodal injection and intensity modulated radiation therapy (IMRT) as determined by the investigator at screening
  • Have an (ECOG) performance status of 0 to 1

Exclusion criteria

Exclusion Criteria:

  • Medical history of: (a) Primary immunodeficiency (b) Organ transplant that requires therapeutic
  • Any of the following within 3 months prior to enrollment/randomization: severe or unstable angina, myocardial infarction, ventricular arrhythmias or heart failure functional classification class III to IV
  • Another concurrent or prior primary within the last 36 months at
  • Known allergies, , or intolerance to any ingredients of JNJ-90301900 crystalline solution, platinum-based doublet chemotherapy (ChT), or durvalumab
  • History of coagulation disorders, including: (a) Active bleeding diathesis or requirement for therapeutic anticoagulation or antiplatelet that cannot be interrupted or altered for JNJ-90301900 injection procedures, (b) Major thromboembolic events (for example, pulmonary embolism, cerebrovascular accident) within 3 months of enrollment or randomization
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Part 1: Cohort A and Cohort B

    Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (cohort A: 22% gross tumor volume \[GTV\] and cohort B: 33% GTV) along with cCRT (concurrent chemotherapy with radiation therapy) followed by consolidation immunotherapy (cIT) to evaluate feasibility of JNJ-90301900 injection procedure.

    Drug: JNJ-90301900 · Biological: Durvalumab · Radiation: Concurrent Chemo/Radiation Therapy (cCRT) · Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin · Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

  • Experimental
    Part 2: Arm A and Arm B

    Participants will receive JNJ-90301900 injected intratumorally and/or intranodally (Arm A: 22% GTV and Arm B: 33% GTV) along with cCRT followed by cIT to evaluate the efficacy and safety of JNJ-90301900.

    Drug: JNJ-90301900 · Biological: Durvalumab · Radiation: Concurrent Chemo/Radiation Therapy (cCRT) · Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin · Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

  • Active comparator
    Part 2: Arm C: (Control treatment)

    Participants will receive treatment with cCRT followed by cIT as control treatment to evaluate the efficacy and safety of JNJ-90301900.

    Biological: Durvalumab · Radiation: Concurrent Chemo/Radiation Therapy (cCRT) · Drug: Concurrent Chemo/Radiation Therapy (cCRT): Carboplatin · Drug: Concurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

Interventions

  • JNJ-90301900 will be injected intratumorally and/or intranodally.

  • BiologicalDurvalumab

    Durvalumab will be administered as intravenous (IV) infusion as cIT.

  • RadiationConcurrent Chemo/Radiation Therapy (cCRT)

    Radiation by intensity modulated radiation therapy (IMRT) will be administered.

  • DrugConcurrent Chemo/Radiation Therapy (cCRT): Carboplatin

    Carboplatin will be administered as IV infusion as platinum-based doublet chemotherapy.

  • DrugConcurrent Chemo/Radiation Therapy (cCRT): Paclitaxel

    Paclitaxel will be administered as IV infusion as platinum-based doublet chemotherapy.

06

What researchers measure

Primary outcomes

  1. Objective Response Rate (ORR) Using Independent Central Review (ICR) Assessment

    ORR is defined as the percentage of participants who have a best response of complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumors (RECIST) version (v) 1.1 using ICR assessments.

    Time frame: Up to 2 Years and 2 months

Secondary outcomes

  1. Objective Response Rate (ORR) Post-cCRT and Pre-cIT

    Objective response rate is defined as percentage of participants who achieve CR or PR, post-concurrent platinum-based doublet chemotherapy with radiation therapy (cCRT) and pre-consolidation immunotherapy (cIT) based on investigator's assessment according to RECIST v1.1.

    Time frame: Up to 12 Weeks

  2. Disease Control Rate (DCR) Post-cCRT and Pre-cIT

    DCR is defined as percentage of participants who achieve CR, PR and stable disease post-cCRT and pre-cIT based on investigator's assessment according to RECIST v1.1.

    Time frame: Up to 12 Weeks

  3. Objective Response Rate (ORR) as Assessed by the Investigator

    ORR is defined as the percentage of participants who have a best response of CR or PR using RECIST v1.1 as assessed by the investigator.

    Time frame: Up to 2 Years and 2 months

  4. Progression Free Survival (PFS)

    PFS is defined as the time from the enrollment/randomization until disease progression or death due to any cause according to RECIST v1.1.

    Time frame: Up to 2 Years and 2 months

  5. Duration of Response (DoR)

    DoR will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of relapse according to RECIST v1.1, or death due to any cause, whichever occurs first.

    Time frame: Up to 2 Years and 2 months

  6. Time to Locoregional Failure (LRF)

    Time to LRF is defined as the time from enrollment/randomization to the first LRF using ICR assessments.

    Time frame: Up to 2 Years and 2 months

  7. Time to Distant Failure (DF)

    Time to DF is defined as the time from enrollment/randomization to the first DF using ICR assessments.

    Time frame: Up to 2 Years and 2 months

  8. Number of Participants with Treatment-Emergent Adverse Event (TEAE) Related to Study Treatment

    TEAE is defined as any new or worsening adverse event (AE) occurring at or after the initial administration of study treatment through the day of last dose of study treatment received plus 30 days or prior to the start of subsequent anticancer therapy (non-durvalumab), whichever is earlier, or any follow-up AE with onset date and time beyond 30 days after the last dose of study treatment but prior to the start of subsequent anticancer therapy, or any AE that is considered treatment-related regardless of the start date of the event. TEAEs related to JNJ-90301900 injection procedure, JNJ-90301900, RT, ChT, or cIT will be reported.

    Time frame: Up to 2 Years and 2 months

  9. Number of Participants Reporting Laboratory Parameters, Physical Examination, Vital Signs Including Eastern Cooperative Oncology Group (ECOG) Performance Status Abnormalities

    Participants with laboratory parameters, physical examination, vital signs including ECOG performance status abnormalities will be reported.

    Time frame: Up to 2 Years and 2 months

07

Study locations

44 of 45 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/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.

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for Dec 2028, 48 months after the start.

Of 317 industry-sponsored phase 2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 59. This study's planned 48 months is above that.

Counting every sponsor, half of 1,047 studies reached it within 48 months; a quarter within 30 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 30, 2024
First posted
Oct 31, 2024
StartActual
Dec 6, 2024
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added. University of Connecticut Health Center is now Completed
Show 2 added (1 France, 1 Australia)
  • CHU Rouen Hopital Charles Nicolle · Rouen, France
  • Chris O'Brien Lifehouse · Camperdown, Australia
across 2 updates, Sep 25, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    1 site added
    Show site
    • Chris O'Brien Lifehouse · Camperdown, Australia
    + 1 other change: verification date
  2. Sep 25, 2026
    1 site added. University of Connecticut Health Center is now Completed
    Show site
    • CHU Rouen Hopital Charles Nicolle · Rouen, France
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06667908
Responsible party
Sponsor
First posted
Oct 31, 2024
Start date
Dec 6, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Johnson & Johnson Enterprise Innovation Inc. Clinical Trial
study director · Johnson & Johnson Enterprise Innovation Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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