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Non-Squamous Non-Small Cell Lung CarcinomaPhase 2NCT03366766

Nivolumab Plus Cisplatin/Pemetrexed or Cisplatin/Gemcitabine as Induction in Resectable Non-Small Cell Lung Cancer

A Phase 2 study testing Nivolumab, Cisplatin and Pemetrexed Disodium in people with Non-Squamous Non-Small Cell Lung Carcinoma and Stage I Non-Small Cell Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in treating patients with stage I-IIIA non-small cell lung cancer that can be removed by surgery. Monoclonal antibodies, such as Nivolumab, may interfere with the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nivolumab, Cisplatin and Pemetrexed Disodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesUnited States
Study dates
20 Dec 2017to 8 Feb 2023
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

  • Pathologically confirmed non small cell lung cancer (NSCLC), not previously treated, with a plan to undergo surgery
  • Stage I-IIIA (stage I tumors must be >= 4 cm) per AJCC 8th edition
  • Tumor sample must be available for PD-L1 testing; archival tissue within 3 months of study enrollment will be used; if archival tissue is unavailable, a fresh biopsy will be taken
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • While blood cells 2000/ul or more
  • Absolute neutrophil count 1500/ul or more
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  • Platelets 100,000/ul or more
  • Hemoglobin 9 g/dl or more; (transfusion permitted)
  • Bilirubin less than or equal to 1.5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x the upper limit of normal
  • Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or serum creatinine less than or equal to 1.5 x (ULN) upper limit of normal
  • Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 21 days of the study enrollment
  • Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; "women of reproductive potential" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level more than 40 mIU/mL
  • Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception
  • All subjects must be able to comprehend and 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
  • Epidermal growth factor receptor (EGFR) or alkaline phosphatase (ALK) activating alteration
  • 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 sever hypersensitivity reaction to any monoclonal antibody
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  • Any history of allergy to the study drug components
  • Any concurrent malignancies- exceptions include- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer that has undergone potentially curative therapy; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 3 years post-diagnosis
  • Participants with an active autoimmune disease or any other condition requiring systemic treatment with either corticosteroids within 14 days (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
  • Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.• Patients with evidence of interstitial lung disease or active, non-infectious pneumonitis. Patients with a history of interstitial lung disease or non-infectious pneumonitis requiring treatment with steroids are also excluded.
  • Patients with a known human immunodeficiency virus infection (HIV 1/2 antibodies) or acquired immunodeficiency syndrome (HIV/AIDS), active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)
  • Patients who have received a live vaccine within 30 days prior initiation of the systemic regimen
  • Patients must not be receiving any other investigational agents
  • Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
  • Women must not be pregnant (as above) or breastfeeding

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Abington Hospital - Jefferson Health

    Abington, Pennsylvania, 19001

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in Treating Patients With Stage I-IIIA Non-small Cell Lung Cancer That Can Be Removed by Surgery

This phase II trial studies how well Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in treating patients with stage I-IIIA non-small cell lung cancer that can be removed by surgery. Monoclonal antibodies, such as Nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as Cisplatin and Pemetrexed Disodium or Gemcitabine Hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride may work better in treating patients with non-small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate major pathologic response (mpCR) in patients with newly diagnosed and untreated non-small cell lung cancer (NSCLC) stage I-IIIA treated with three courses of induction nivolumab added to either cisplatin/pemetrexed or cisplatin/gemcitabine prior to surgery.

SECONDARY OBJECTIVES:

  1. Safety. II. Complete pathologic response at all sites of disease. III. Major pathologic response rate at primary site. IV. Clinical complete response rate. V. 1 year progression free survival (PFS). VI. Overall survival.

TERTIARY OBJECTIVES:

  1. To explore whether PDL1 expression is associated with treatment response. II. To explore whether there is a net change in the Th1/Th2 ratio (IFN-gamma, IL-4, IL10, etc.) or cell subset frequencies (M2 monocytes, myeloid-derived suppressor cells, etc.) within a patient's peripheral blood either at baseline or in response to treatment is associated with treatment response.

III. To explore whether exosomes or other immune related serum biomarkers change after combination therapy.

IV. To explore the predictive value of serial cell free deoxyribonucleic acid (DNA) levels and response.

  1. PD-L1 assessment in tumor.
Being tested
Nivolumab, Cisplatin, Pemetrexed Disodium, Gemcitabine Hydrochloride
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NivolumabBiological

    Also called BMS-936558, NIVO, Opdivo, ONO-4538

    Given IV

  • CisplatinDrug

    Also called (SP-4-2)-Diamminedichloroplatinum, Abiplatin, Blastolem, Briplatin

    Given IV

  • Pemetrexed DisodiumDrug

    Also called Alimta, N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt

    Given IV

  • Gemcitabine HydrochlorideDrug

    Also called Hydrochloride, Difluorodeoxycytidine Hydrochloride, Gemzar

    Given IV

Study groups in NCT03366766
Study groupRoleWhat they receive
Cohort I (nivolumab, cisplatin, pemetrexed disodium)ExperimentalPatients with non-squamous lung cancer receive nivolumab IV over 30 minutes, cisplatin IV over 60-120 minutes, and pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity
Receives: Biological: Nivolumab; Drug: Cisplatin; Drug: Pemetrexed Disodium
Cohort I (nivolumab, cisplatin, gemcitabine hydrochloride)ExperimentalPatients with squamous lung cancer receive nivolumab IV over 30 minutes on day 1, cisplatin IV over 60-120 minutes on day 1, and gemcitabine hydrochloride IV over 1 hour on days 1 and 8. Courses repeat every 3 weeks for up to 9 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Nivolumab; Drug: Gemcitabine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathologic Response (mpCR) Defined as < 10% Viable Tumor

    For the primary endpoint, the major pathologic response rate was calculated as a percentage of patients who achieved a major pathologic response (i.e., <10% viable tumor) or pathologic complete response. Then, the major pathologic response rate was tested with the exact binomial test under the null hypothesis that the true major pathologic response rate is ≤ 0.19. The corresponding 95% Clopper-Pearson confidence limits were reported too.

    Measured: Up to 63 days

Secondary outcomes (6)

  1. Number of Adverse Events

    Number of adverse events according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Safety data will be summarized descriptively.

    Measured: Up to 6 months

  2. Progression Free Survival

    The distribution of progression-free survival will be estimated using the Kaplan-Meier method.

    Measured: At 1 year

  3. Overall Survival

    The distribution of overall survival will be estimated using the Kaplan-Meier method.

    Measured: Up to 1 year

  4. Overall Clinical Response

    Will be summarized by presence of baseline measurable disease. Overall clinical response measured by Chest CT at 3 timepoints

    Measured: At Week 10

  5. Overall Clinical Response

    Will be summarized by presence of baseline measurable disease. Overall clinical response measured by Chest CT at 3 timepoints

    Measured: At Month 3

  6. Overall Clinical Response

    Will be summarized by presence of baseline measurable disease. Overall clinical response measured by Chest CT at 3 timepoints

    Measured: At Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2017
  2. Study start20 Dec 2017
  3. Primary completion6 Dec 2020
  4. Study completion8 Feb 2023

Why it stopped: slow accrual and lack of additional funding

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03366766
Sponsor's protocol ID
17P.556
Other IDs
JT 11371
Status last verified
Feb 2026
First submitted
4 Dec 2017
Last updated
20 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, Cisplatin and Pemetrexed Disodium in people with Non-Squamous Non-Small Cell Lung Carcinoma and Stage I Non-Small Cell Lung Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 2 sites 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 15 inclusion and 15 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 20 Feb 2026). 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?

Major Pathologic Response (mpCR) Defined as < 10% Viable Tumor (time frame: Up to 63 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03366766.

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 20 Feb 2026.

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