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Non Small Cell Lung CancerPhase 2NCT04015778

A Exploratory Study of Nivolumab Monotherapy or in Combination With Nab-paclitaxel and Carboplatin in Early Stage NSCLC in China

A Phase 2 study testing Nivolumab, carboplatin and nab-paclitaxel in people with Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 (B7 H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and augmenting the host antitumor response. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
Nivolumab, carboplatin and nab-paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
1 siteChina
Study dates
8 Aug 2019to 30 Aug 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed Stage II or IIIA non-small cell lung cancer (NSCLC) (per TNM 8th edition; AJCC 8th edition), including T3N2M0 tumors, deemed to be completely resectable.
  • Regardless of PD-L1 expression status.
  • EGFR and ALK wild-type. If testing is performed, it should be conducted locally using assays approved by the National Medical Products Administration (NMPA/formerly CFDA).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Presence of at least one measurable lesion according to RECIST version 1.1.

Who cannot join

  • Presence of locally advanced, inoperable or metastatic disease
  • Participants with active, known or suspected autoimmune disease
  • Prior treatment with any drug that targets T cell co-stimulations pathways (such as checkpoint inhibitors)
  • EGFR mutation or ALK transsituation (+)
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Nivolumab (BMS-936558) is a fully human, IgG4 (kappa) isotype mAb that binds PD-1 on activated immune cells and disrupts engagement of the receptor with its ligands PD-L1 (B7 H1/CD274) and PD-L2 (B7-DC/CD273), thereby abrogating inhibitory signals and augmenting the host antitumor response. In early clinical trials, nivolumab has demonstrated activity in several tumor types, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC).

Nivolumab is in clinical development for the treatment of patients with NSCLC, RCC, melanoma, squamous cell carcinoma of the head and neck (SCCHN) and other tumors (eg, glioblastoma multiforme, mesothelioma, small cell lung cancer, gastric).

Read more

Nivolumab is approved in the United States (US), European Union, and other countries for the treatment of patients with unresectable or metastatic melanoma, advanced NSCLC with progression on or after platinum-based chemotherapy, advanced RCC whose disease progressed on an antiangiogenic therapy, classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin treatment, and recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.

The proposed study will evaluate the efficacy and safety of preoperative administration of Nivolumab or Nivolumab combined with nab-paclitaxel and carboplatin in neoadjuvant setting and administration of Nivolumab in adjuvant setting in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune microenvironment and circulating immune cells in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting. Ultimately, it is highly desirable to discover prospective biomarkers of response and toxicity to allow patients with NSCLC who are most likely to derive benefit to receive anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective treatment for patients who are unlikely to benefit.

Being tested
Nivolumab, carboplatin, nab-paclitaxel, Radical resection for lung cancer, Radical radiation therapy
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

    Nivolumab 360 mg IV (administered intravenously for more than 30 minutes) every 3 weeks

  • carboplatinDrug

    AUC 5, d1 every three weeks

  • nab-paclitaxelDrug

    135 mg/m2, d1, 8

  • Radical resection for lung cancerProcedure or surgery

    Including lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy. Segmentectomy and wedge resection are not permitted.

  • Radical radiation therapyRadiation

    In Part 3, for patients who are assessed by a Multidisciplinary Team (MDT) as unable to achieve R0 resection following neoadjuvant chemo-immunotherapy induction, the recommended radiotherapy regimen is: 60 Gy in 30 fractions (5 fractions per week) to 95% of the planning target volume (PTV).

  • Chemotherapy (Cisplatin)Drug

    Part 3: For patients who are determined by a Multidisciplinary Team (MDT) to be ineligible for R0 resection following neoadjuvant chemo-immunotherapy induction and require definitive radiotherapy, concurrent chemotherapy will be administered. The regimen consists of cisplatin 30 mg/m² administered once weekly

  • NivolumabBiological

    Within 6 weeks after definitive surgery, subjects in each cohort who are assessed to have benefited from neoadjuvant therapy (CR, PR, or SD) and have adequately recovered from surgery may receive adjuvant nivolumab (360 mg via IV infusion over at least 30 minutes, every 3 weeks) for up to 12 months, or until disease recurrence or unacceptable toxicity.

Study groups in NCT04015778
Study groupRoleWhat they receive
Part 1: Nivolumab MonoExperimentalIn arm A, 24 participants will be enrolled into this arm according to PD-L1 expressing level (≥50%).Arm A consists of 3 cycles of neoadjuvant nivolumab (360mg every 3 weeks), and adjuvant nivolumab (360mg IV, every 3 weeks) up to 12 months
Receives: Biological: Nivolumab; Procedure: Radical resection for lung cancer
Part 1: Nivolumab Plus ChemoExperimentalIn arm B, up to 12 participants will be enrolled into each subgroup according to PD-L1 expressing level (<1% and 1%-49%).arm B consists of 3 cycles of neoadjuvant nivolumab (360mg every 3 weeks) with nab-paclitaxel and carboplatin(nab-paclitaxel 135 mg/m2, d1, 8 and carboplatin AUC 5, d1 every three weeks ), and adjuvant nivolumab (360mg IV, every 3 weeks) up to 12 months
Receives: Biological: Nivolumab; Drug: carboplatin; Drug: nab-paclitaxel; Procedure: Radical resection for lung cancer
Part:2: Exploratory cohortExperimentalIn part 2，the treatment regimen consists of three cycles of neoadjuvant nivolumab (360 mg every 3 weeks) in combination with nab-paclitaxel and carboplatin (nab-paclitaxel 135 mg/m² on days 1 and 8, and carboplatin AUC 5 on day 1, every 3 weeks), followed by adjuvant nivolumab (360 mg every 3 weeks, administered via IV infusion over at least 30 minutes) for up to 12 months. A total of 53 subjects will be enrolled in this study, regardless of PD-L1 expression.
Receives: Biological: Nivolumab; Drug: carboplatin; Drug: nab-paclitaxel; Procedure: Radical resection for lung cancer
Part 3: Real-world cohortExperimentalPart 3 aims to evaluate the real-world effectiveness of neoadjuvant chemoimmunotherapy in patients with EGFR/ALK wild-type, potentially resectable or unresectable Stage III NSCLC. Treatment Paradigm: Eligible subjects will receive 3 cycles of neoadjuvant chemoimmunotherapy. Subsequently, a Multidisciplinary Team (MDT) will evaluate and determine the optimal definitive local therapy, triage patients to either radical resection or concurrent chemoradiotherapy (CCRT). Following the completion of local therapy, patients will receive adjuvant or consolidation immunotherapy for a duration of 1 year, administered every 3 weeks (Q3W). Sample Size: The planned enrollment for Part 3 is 215 patients.
Receives: Biological: Nivolumab; Drug: carboplatin; Drug: nab-paclitaxel; Procedure: Radical resection for lung cancer; Radiation: Radical radiation therapy; Drug: Chemotherapy (Cisplatin)

What is being measured

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

  1. MPR (Major Pathological Response) rate

    As the primary outcome in part 1. MPR rate, defined as the number of participants with <10% residual tumor in lung and lymph nodes, divided by the number of treated participants for each arm. Viable tumors in situ carcinoma should not be included in the MPR calculation.

    Measured: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks

  2. EFS

    Primary Outcome for Part 2.

    Outcome Measure Definition: Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events:

    Disease progression that precludes surgical treatment;

    Local or distant recurrence;

    Death from any cause.

    Progression and recurrence will be assessed by the investigator according to RECIST 1.1. Subjects who die without documented disease progression or recurrence will be considered to have experienced an EFS event on the date of death.

    Measured: Since the last patient was enrolled for follow-up for 36 months

  3. 18 months EFS rate

    Primary Outcome for Part 3.

    Outcome Measure Definition: 18months Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events:

    Disease progression that precludes surgical treatment;

    Local or distant recurrence;

    Death from any cause.

    Progression and recurrence will be assessed by the investigator according to RECIST 1.1. Subjects who die without documented disease progression or recurrence will be considered to have experienced an EFS event on the date of death.

    Measured: The patient was followed up for 18 months after frist cycle neoajuvant treatment.

  4. Surgical Conversion Rate

    The primary endpoint of Part 3 is the surgical conversion rate, defined as the proportion of patients who successfully undergo definitive surgery following neoadjuvant chemoimmunotherapy, relative to the total enrolled population (Intent-to-Treat [ITT] analysis set).

    Statistical Analysis: The surgical conversion rate will be summarized descriptively using frequencies and percentages. The two-sided 95% exact confidence interval (CI) for the proportion will be calculated using the Clopper-Pearson method.

    Measured: Perioperative/Periprocedural

Secondary outcomes (8)

  1. MPR (Major Pathological response) rate in 2 subgroups patients (PD-L1 <1%, and 1-49%) in Arm B

    In part 1

    Measured: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks

  2. Proportion of resection without delay

    In part 1and 2

    Measured: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks

  3. Number of Participants with Adverse Events

    In parts 1 and 2 Safety and tolerability will be measured by incidence of AE, SAE, immune related AEs, deaths, and laboratory abnormalities

    Measured: During the treatment period, within at least 100 days after the cessation of neoadjuvant therapy, within 90 days after surgery, and within 30 days after adjuvant therapy.

  4. MRP rate

    Also, as the primary outcome in part 1. MPR rate, defined as number participants with <10% residual tumor in lung and lymph nodes, divided by the number of treated participants for each arm Viable tumors in situ carcinoma should not be included in MPR calculation.

    Measured: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks

  5. The EFS rates of all subjects with different PD-L1 expression statuses (PD-L1 < 1%, 1-49% and ≥ 50%)

    In parts 1 and 2. Outcome Measure Definition: Event-Free Survival (EFS) is defined as the time from randomization to the first occurrence of any of the following events:

    Disease progression that precludes surgical treatment;

    Local or distant recurrence;

    Death from any cause.

    Progression and recurrence will be assessed by the investigator according to RECIST 1.1. Subjects who die without documented disease progression or recurrence will be considered to have experienced an EFS event on the date of death.

    Measured: From date of enrollment up to the end of study, 5 years.

  6. 12 months EFS rate

    In part 3, the 12-month EFS rate is the proportion of subjects who are alive and event-free at 12 months after the start of treatment.

    Measured: After 12 months of enrollment for all patientsAfter 12 months of enrollment for all patients

  7. OS

    In part 3, OS is defined as the time from the start of treatment to death for any reason

    Measured: From the date of enrollment until the date of death, assessed up to 100 months

  8. TDDM (Time to Death or Distant Metastasis)

    In part 3, TDDM is defined as the start of the first treatment to distant metastasis, or death from any cause, whichever occurs first

    Measured: From the date of the first dose of study treatment until the date of first documented distant metastasis or death from any cause, whichever occurs first, assessed up to approximately 60 months.

Timeline

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

  1. First posted11 Jul 2019
  2. Study start8 Aug 2019
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Aug 2026 (estimated)

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
Single group
Masking
None (open label)
Enrolment
316 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04015778
Sponsor's protocol ID
CTONG 1804
Status last verified
Apr 2026
First submitted
4 Jul 2019
Last updated
20 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Liu SY, Dong S, Yang XN, Liao RQ, Jiang BY, Wang Q, Ben XS, Qiao GB, Lin JT, Yan HH, Yan LX, Nie Q, Tu HY, Wang BC, Yang JJ, Zhou Q, Li HR, Liu K, Wu W, Liu SM, Zhong WZ, Wu YL. Neoadjuvant nivolumab with or without platinum-doublet chemotherapy based on PD-L1 expression in resectable NSCLC (CTONG1804): a multicenter open-label phase II study. Signal Transduct Target Ther. 2023 Dec 6;8(1):442. doi: 10.1038/s41392-023-01700-4.

    PubMed 38057314

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nivolumab, carboplatin and nab-paclitaxel in people with Non Small Cell Lung Cancer, run by Guangdong Association of Clinical Trials at 1 site in China.

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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. 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 China. 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?

This study is still under way. Results are not available in the source record yet.

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?

MPR (Major Pathological Response) rate (time frame: The patients considered to be technically resectable will undergo resection，an expected average of 13 weeks). The study lists 4 primary outcomes in all. 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 NCT04015778, which also lists 1 linked publication.

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 May 2026.

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