Lung Cancer, Nonsmall CellPhase 2NCT06003075
Induction Chemo-Nivo in Unresectable Stage III NSCLC
A Phase 2 study testing Nivolumab and Chemotherapy, Nivolumab and Post Induction Surgery in people with Lung Cancer, Nonsmall Cell and Lung Cancer Stage III, run by Ralph G Zinner at 1 site in United States.
Trial summary
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Lung Cancer Stage III
- What is being tested?
- Nivolumab and Chemotherapy, Nivolumab and Post Induction Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2023to 5 Jul 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated
- PD-L1 level needs to be measured with values 0-100% eligible
- EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes
- ECOG Performance Status ≤ 1
- Adequate organ and marrow function
- Adequate pulmonary reserve (e.g., FVC, FEV1, TLC, FRC, and DLCO) capable of tolerating the proposed lung resection
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- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification class 2B or better
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
- Any prior radiotherapy to the lung
- Any prior treatment for NSCLC
- Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Any history of a severe hypersensitivity reaction to any monoclonal antibody
- Any history of allergy to the study drug components
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- primary tumors involving the esophagus
- pancoast tumors
- Patients cannot have primary tumors which would remain unresectable
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nivolumab or other agents used in study
- Any active or history of autoimmune disease (including any history of inflammatory bowel disease), or history of syndrome that required systemic steroids or immunosuppressive medications
- Ongoing requirement for systemic corticosteroids greater than the equivalent of prednisone 10mg
- previous malignancies
- history of interstitial lung disease
- Patients requiring continuous supplemental oxygen
- Use of any live vaccines against infectious diseases (e.g., influenza, varicella. etc.) within 4 weeks (28 days) of initiation of study therapy
- Active systemic infection requiring therapy
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC)
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
- Conditions
- Lung Cancer, Nonsmall Cell, Lung Cancer Stage III
- Being tested
- Nivolumab and Chemotherapy, Nivolumab, Post Induction Surgery, Post Induction XRT
- Keywords
- Nivolumab, unresectable
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab and ChemotherapyCombination product
3 cycles of the proposed nivolumab + platinum doublet (either pemetrexed + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for non squamous; or gemcitabine + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for squamous) will be administered then CT and biopsy, followed by surgery with option for post-op NIVO-XRT, then 12 cycles NIVO at 480 mg IV every 4 weeks for 12 weeks
NivolumabDrug
Also called NIVO
Participants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation
Post Induction SurgeryProcedure or surgery
Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by surgery in patients whose tumors were unresectable stage IIIA-C at baseline on the basis of lymphadenopathy and are determined to be resectable after responding to induction chemotherapy-nivolumab. The participants have an option for post op XRT, then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles
Post Induction XRTRadiation
Induction Chemo-NIVO x 3 cycles then CT and biopsy, followed by concurrent Chemo and Nivo XRT (60Gy). Participants will receive concurrent thoracic radiation therapy using a standardized 3DCRT or IMRT technique on a linear accelerator operating at 2:6 MV beam energy. The target total dose of thoracic radiation therapy will be 60 Gy in 30 daily fractions of 2 Gy prescribed to the PTV. The participants then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Combination Chemotherapy and Nivolumab and Surgery | Experimental | Patients with lung cancer receiving combination therapy with surgery Receives: Combination Product: Nivolumab and Chemotherapy; Drug: Nivolumab; Procedure: Post Induction Surgery; Radiation: Post Induction XRT |
| Combination Chemotherapy and Nivolumab and Radiation | Experimental | Patients with lung cancer receiving combination therapy with radiation Receives: Combination Product: Nivolumab and Chemotherapy; Drug: Nivolumab; Radiation: Post Induction XRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate After Induction
post induction radiographic response by cat scan
Measured: 9 weeks
Secondary outcomes (7)
Change in Toxicity
To assess safety, investigators will evaluate the rate of toxicity as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.
Measured: through study completion, up to 18 months
Percent of Participants Receiving Surgery
Rate of converting non-surgical stage III(A-C) to surgically resectable disease
Measured: date of surgery, approximately 10 weeks
Pathologic Complete Response (pCR)
Number of participants with Pathologic Complete Response. Pathologic complete response (pCR) is defined by a surgical pathology specimen
Measured: post surgery, approximately 10 weeks
Major Pathological Response (MPR)
MPR rate, defined as number of participants with ≤ 10% residual tumor in lung and lymph nodes
Measured: post surgery, approximately 10 weeks
Progression Free Survival (PFS)
PFS is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Measured: 2 years
Overall Survival (OS)
defined as the duration of time from start of treatment to time of death
Measured: 2 years
Change in Patient-reported Quality of Life as Measured by FACT-TOI
patient-reported Quality of Life as measured by FACT-TOI (Functional Assessment of Cancer Therapy - Trial Outcome Index); defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS (lung cancer scale) scores obtained from 7-item questionnaires from the FACT-L (Version 4.0). Questions are on a 5-point scale from 0-4, where 0 = "not at all" and 4 = "very much." Scores range from 0 to 84; higher score indicates better physical aspects of quality of life (QoL).
Measured: through study completion, up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Dec 2023
- Primary completion5 Jul 2024
- Study completion5 Jul 2024
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Chemo, biopsy, surgery with option for post op chemo or no surgery with concurrent chemo
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ralph G Zinner
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Ralph G Zinner, University of Kentucky
- Investigators
- Ralph Zinner, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003075
- Sponsor's protocol ID
- 85869
- Status last verified
- Apr 2025
- First submitted
- 15 Aug 2023
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Induction Platinum Doublet in Combination With Nivolumab Followed by Surgery or Concurrent Chemoradiation in Unresectable Stage IIIA-C Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT06003075
- Acronym / sponsor ID
- 85869
- Conditions
- Lung Cancer, Nonsmall Cell, Lung Cancer Stage III
- Keywords
- Nivolumab, unresectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Ralph G ZinnerUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 13 Dec 2023 (actual)
- Primary completion
- 5 Jul 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 30 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the response rate, safety, and effectiveness of a combination therapy in patients with lung cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Chemo, biopsy, surgery with option for post op chemo or no surgery with concurrent chemo
| Arm | Type | Receives |
|---|---|---|
| Combination Chemotherapy and Nivolumab and Surgery | Experimental | Combination Product: Nivolumab and Chemotherapy, Drug: Nivolumab, Procedure: Post Induction Surgery, Radiation: Post Induction XRTPatients with lung cancer receiving combination therapy with surgery |
| Combination Chemotherapy and Nivolumab and Radiation | Experimental | Combination Product: Nivolumab and Chemotherapy, Drug: Nivolumab, Radiation: Post Induction XRTPatients with lung cancer receiving combination therapy with radiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Squamous and non-squamous non-small cell lung cancer that is at baseline, unresectable stage IIIA-IIIC (8th edition AJCC) and not previously treated
- PD-L1 level needs to be measured with values 0-100% eligible
- EGFR/ALK/ROS1 Wild Type or unknown genetic alterations in these genes
- ECOG Performance Status ≤ 1
- Adequate organ and marrow function
Key exclusion criteria (20 listed)
- Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
- Any prior radiotherapy to the lung
- Any prior treatment for NSCLC
- Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
- Any history of a severe hypersensitivity reaction to any monoclonal antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nivolumab and Chemotherapy3 cycles of the proposed nivolumab + platinum doublet (either pemetrexed + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for non squamous; or gemcitabine + carbo/cis or paclitaxel + carbo or docetaxel + carbo/cis for squamous) will be administered then CT and biopsy, followed by surgery with option for post-op NIVO-XRT, then 12 cycles NIVO at 480 mg IV every 4 weeks for 12 weeks | Combination product | Combination Chemotherapy and Nivolumab and Radiation, Combination Chemotherapy and Nivolumab and Surgery |
| NivolumabAlso: NIVOParticipants will receive NIVO at 480 mg IV every 4 weeks for 12 cycles after either surgery or treated with concurrent chemotherapy-nivolumab-radiation | Drug | Combination Chemotherapy and Nivolumab and Radiation, Combination Chemotherapy and Nivolumab and Surgery |
| Post Induction SurgeryInduction Chemo-NIVO x 3 cycles then CT and biopsy, followed by surgery in patients whose tumors were unresectable stage IIIA-C at baseline on the basis of lymphadenopathy and are determined to be resectable after responding to induction chemotherapy-nivolumab. The participants have an option for post op XRT, then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles | Procedure or surgery | Combination Chemotherapy and Nivolumab and Surgery |
| Post Induction XRTInduction Chemo-NIVO x 3 cycles then CT and biopsy, followed by concurrent Chemo and Nivo XRT (60Gy). Participants will receive concurrent thoracic radiation therapy using a standardized 3DCRT or IMRT technique on a linear accelerator operating at 2:6 MV beam energy. The target total dose of thoracic radiation therapy will be 60 Gy in 30 daily fractions of 2 Gy prescribed to the PTV. The participants then will receive NIVO at 480 mg IV every 4 weeks for 12 cycles. | Radiation | Combination Chemotherapy and Nivolumab and Radiation, Combination Chemotherapy and Nivolumab and Surgery |
Primary outcome
Response Rate After Induction
Time frame: 9 weeks
post induction radiographic response by cat scan
7 secondary outcomes
Change in Toxicity
Time frame: through study completion, up to 18 months
Percent of Participants Receiving Surgery
Time frame: date of surgery, approximately 10 weeks
Pathologic Complete Response (pCR)
Time frame: post surgery, approximately 10 weeks
Major Pathological Response (MPR)
Time frame: post surgery, approximately 10 weeks
Progression Free Survival (PFS)
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Change in Patient-reported Quality of Life as Measured by FACT-TOI
Time frame: through study completion, up to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralph Zinner, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Chemotherapy, Nivolumab and Post Induction Surgery in people with Lung Cancer, Nonsmall Cell and Lung Cancer Stage III, run by Ralph G Zinner at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate After Induction (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.