18 and older, any sex, with Stage I Lung Non-Small Cell Cancer AJCC v7 or Stage IA Lung Non-Small Cell Carcinoma AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Major Pathologic Response (mPR)Primary· The lung resection specimen was collected at surgery.
The percentage of viable tumor cells was averaged across all reviewed tumor slides from the lung resection specimen. The specimen was reviewed by two pathologists and average score was used. Tumors with ≤ 10% of viable tumor cells were considered to have undergone MPR. Patients who did not have surgery was considered to be no MPR.
MPR
Group
Value
95% CI
Arm A - Nivolumab
5
Arm B - Nivolumab + Ipilimumab
8
Arm C - Nivolumab + Chemotherapy
7
Arm D - Nivolumab + Ipilimumab + Chemotherapy
11
No MPR
Group
Value
95% CI
Arm A - Nivolumab
18
Arm B - Nivolumab + Ipilimumab
13
Arm C - Nivolumab + Chemotherapy
15
Arm D - Nivolumab + Ipilimumab + Chemotherapy
11
Pathologic Complete Response (pCR)Secondary· The lung resection specimen was collected at surgery.
The percentage of viable tumor cells was averaged across all reviewed tumor slides from the lung resection specimen. The specimen was reviewed by two pathologists and average score was used. Tumors with 0% of viable tumor cells were considered to have undergone pCR. Patients who did not have surgery was considered to be no pCR.
pCR
Group
Value
95% CI
Arm A - Nivolumab
2
Arm B - Nivolumab + Ipilimumab
6
Arm C - Nivolumab + Chemotherapy
4
Arm D - Nivolumab + Ipilimumab + Chemotherapy
4
No pCR
Group
Value
95% CI
Arm A - Nivolumab
21
Arm B - Nivolumab + Ipilimumab
15
Arm C - Nivolumab + Chemotherapy
18
Arm D - Nivolumab + Ipilimumab + Chemotherapy
18
Radiographic ResponseSecondary· Reassessment after induction therapy
Radiographic response to induction treatment was assessed by RECIST version 1.1
CR
Group
Value
95% CI
Arm A - Nivolumab
0
Arm B - Nivolumab + Ipilimumab
1
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
0
PR
Group
Value
95% CI
Arm A - Nivolumab
5
Arm B - Nivolumab + Ipilimumab
3
Arm C - Nivolumab + Chemotherapy
9
Arm D - Nivolumab + Ipilimumab + Chemotherapy
6
SD
Group
Value
95% CI
Arm A - Nivolumab
15
Arm B - Nivolumab + Ipilimumab
13
Arm C - Nivolumab + Chemotherapy
13
Arm D - Nivolumab + Ipilimumab + Chemotherapy
14
PD
Group
Value
95% CI
Arm A - Nivolumab
3
Arm B - Nivolumab + Ipilimumab
3
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
1
Not evaluable
Group
Value
95% CI
Arm A - Nivolumab
0
Arm B - Nivolumab + Ipilimumab
1
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
1
Overall Survival (OS)Secondary· In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively
Overall survival was defined as the time from randomization (in Arm A and Arm B) or treatment initiation (in Arm C and Arm D) to the time of death from all causes or to the time of last follow-up.
Group
Value
95% CI
Arm A - Nivolumab
NA
NA – NA
Arm B - Nivolumab + Ipilimumab
NA
NA – NA
Arm C - Nivolumab + Chemotherapy
NA
NA – NA
Arm D - Nivolumab + Ipilimumab + Chemotherapy
NA
NA – NA
Event-free Survival (EFS)Secondary· In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively.
EFS was defined as the time from randomization (in Arm A and Arm B) or treatment initiation (in Arm C and Arm D) to any progression of primary lung cancer precluding planned surgery, any progression or recurrence (as assessed by imaging and/or histopathologically) of primary lung cancer after surgery, any progression of primary lung cancer in patients without surgery or death from all causes or to the time of last imaging.
Group
Value
95% CI
Arm A - Nivolumab
NA
NA – NA
Arm B - Nivolumab + Ipilimumab
NA
20.1 – NA
Arm C - Nivolumab + Chemotherapy
NA
21.7 – NA
Arm D - Nivolumab + Ipilimumab + Chemotherapy
NA
NA – NA
Residual Tumor ClassificationSecondary· At surgery
The residual tumor (R) classification measures how well the lung tumor was removed by surgery in the anatomic extent. R0 means a complete resection. R1 means a macroscopically complete resection but with microscopic tumor at the surgical margin. R2 means a resection that leaves gross tumor behind. R0 resection is a better surgical outcome than R1, R2 resections and R2 is the worst surgical outcome. The number of R0, R1 and R2 resections were reported among the patients who underwent surgery.
R0
Group
Value
95% CI
Arm A - Nivolumab
21
Arm B - Nivolumab + Ipilimumab
16
Arm C - Nivolumab + Chemotherapy
20
Arm D - Nivolumab + Ipilimumab + Chemotherapy
19
R1
Group
Value
95% CI
Arm A - Nivolumab
0
Arm B - Nivolumab + Ipilimumab
0
Arm C - Nivolumab + Chemotherapy
1
Arm D - Nivolumab + Ipilimumab + Chemotherapy
1
R2
Group
Value
95% CI
Arm A - Nivolumab
0
Arm B - Nivolumab + Ipilimumab
0
Arm C - Nivolumab + Chemotherapy
1
Arm D - Nivolumab + Ipilimumab + Chemotherapy
0
No surgery
Group
Value
95% CI
Arm A - Nivolumab
2
Arm B - Nivolumab + Ipilimumab
5
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
2
30-day Postoperative ComplicationSecondary· Within 30 days after surgery
The number of patients who had complications including pulmonary, cardiac, gastrointestinal, genitourinary, neurological, and wound within 30 days after surgery
Complication
Group
Value
95% CI
Arm A - Nivolumab
8
Arm B - Nivolumab + Ipilimumab
5
Arm C - Nivolumab + Chemotherapy
7
Arm D - Nivolumab + Ipilimumab + Chemotherapy
13
No complication
Group
Value
95% CI
Arm A - Nivolumab
13
Arm B - Nivolumab + Ipilimumab
11
Arm C - Nivolumab + Chemotherapy
15
Arm D - Nivolumab + Ipilimumab + Chemotherapy
7
No surgery
Group
Value
95% CI
Arm A - Nivolumab
2
Arm B - Nivolumab + Ipilimumab
5
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
2
90-day MortalitySecondary· Within 90 days after surgery
The number of patients who died within 90 days after surgery
Dead
Group
Value
95% CI
Arm A - Nivolumab
1
Arm B - Nivolumab + Ipilimumab
0
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
0
Alive
Group
Value
95% CI
Arm A - Nivolumab
20
Arm B - Nivolumab + Ipilimumab
16
Arm C - Nivolumab + Chemotherapy
22
Arm D - Nivolumab + Ipilimumab + Chemotherapy
20
No surgery
Group
Value
95% CI
Arm A - Nivolumab
2
Arm B - Nivolumab + Ipilimumab
5
Arm C - Nivolumab + Chemotherapy
0
Arm D - Nivolumab + Ipilimumab + Chemotherapy
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were monitored for each participant from the first study intervention to approximately up to 8 weeks after surgery. After the end of treatment evaluation, all-cause mortality monitoring was performed as permitted by study protocol. In Arms A and B, the cutoff date was 2020-2-25. The median follow-up time frame was 22.2 months. In Arms C and D, the cutoff date was 2022-7-18. The median follow-up time frames were 39.2 and 24.0 months respectively..
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Arm A - Nivolumab
Serious: 4/23 (17%)
Deaths: 1/23
Arm B - Nivolumab + Ipilimumab
Serious: 3/21 (14%)
Deaths: 1/21
Arm C - Nivolumab + Chemotherapy
Serious: 7/22 (32%)
Deaths: 3/22
Arm D - Nivolumab + Ipilimumab + Chemotherapy
Serious: 3/22 (14%)
Deaths: 3/22
Serious adverse events (14 terms)
Reaction
System
Arm A - Nivolumab
Arm B - Nivolumab + Ipilim…
Arm C - Nivolumab + Chemot…
Arm D - Nivolumab + Ipilim…
Febrile neutropenia
Blood and lymphatic system disorders
—
—
—
—
Lung infection
Infections and infestations
—
—
—
—
Sepsis
Infections and infestations
—
—
—
—
Diarrhea/Colitis
Gastrointestinal disorders
—
—
—
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Hypoxia
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Thromboembolic event (pulmonary embolism)
Vascular disorders
—
—
—
—
Atypical Guillain-Barré syndrome
Nervous system disorders
—
—
—
—
Fall
Injury, poisoning and procedural complications
—
—
—
—
Hemoptysis
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Hypercalcemia
Metabolism and nutrition disorders
—
—
—
—
Pericardial tamponade
Cardiac disorders
—
—
—
—
Hyponatremia
Metabolism and nutrition disorders
—
—
—
—
Respiratory failutre
Respiratory, thoracic and mediastinal disorders
—
—
—
—
Other adverse events (175 terms — click to expand)
This phase II trial studies how well nivolumab works when given alone and in combination with ipilimumab or chemotherapy in treating patients with previously untreated stage I-IIIA non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cisplatin, docetaxel, and pemetrexed, 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 with ipilimumab or chemotherapy may work better in treating patients with non-small cell lung cancer compared to chemotherapy alone.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
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· Phase 3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03158129.