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Non Small Cell Lung CancerPhase 2NCT04422392

Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer

A Phase 2 study testing Carboplatin, Pemetrexed or Nab-paclitaxel and PD-1 antibody in people with Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 8 sites in China.

Terminated

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

Official record
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Trial summary

This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA-N2 non-small cell lung cancer. 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?
Carboplatin, Pemetrexed or Nab-paclitaxel and PD-1 antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
8 sitesChina
Study dates
13 Jul 2020to 30 Sep 2022
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Written informed consent provided.
  • Males or females aged ≥18 years.
  • Pathologically diagnosed of non-small cell lung cancer.
  • Diagnosed as stage IIIA- N2.The diagnosis standard of N2 is as below: Pts with resectable stage IIIA-N2 NSCLC confirmed by mediastinoscopy or EBUS and PET/CT.
  • Tumor should be considered resectable before study entry by a multidisciplinary team.
  • ECOG (Performance status) 0-1.
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  • Screening laboratory values must meet the following criteria and should be obtained within 7 days prior to randomization.
  • Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 x×109/L iii. Hemoglobin > 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or >40% predicted value viii. INR/APTT within normal limits.
  • Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 7 days before randomization.
  • All sexually active men and women of childbearing potential must use an effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 12 months following the last administration of trial drugs.
  • Patient capable of proper therapeutic compliance and accessible for correct follow-up.
  • Measurable or evaluable disease (according to RECIST 1.1 criteria).

Who cannot join

  • All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 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.
  • Patients with a history of interstitial lung disease cannot be included if they have symptomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.
  • Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy.
  • Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.
  • Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.
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  • Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways.
  • Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
  • Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  • Patients with history of allergy to study drug components excipients.
  • Women who are pregnant or in the period of breastfeeding.
  • Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Zhejiang Cancer Hospita

    Hangzhou, Zhejiang

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • Changzheng Hospital

    Shanghai, Shanghai Municipality, 200000

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200092

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200092

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200092

  • Shuguang Hospital

    Shanghai, Shanghai Municipality, 200092

  • The Second Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

Other trials in China

About this study

Official title: Neoadjuvant PD-1 Antibody Plus Chemotherapy in Resectable Stage IIIA-N2 Non-Small-Cell Lung Cancer: A Randomized Phase II Study

This is a randomized, open label study designed to evaluate the efficacy and safety of neoadjuvant PD-1 antibody plus chemotherapy followed by surgery in resectable stage IIIA-N2 non-small cell lung cancer.

Read the detailed description

This is an open-label, randomised, two-arm, phase II, multi-centre clinical trial. The proposed study will evaluate the efficacy and safety of preoperative administration PD-1 antibody plus chemotherapy in patients resectable stage IIIA-N2 NSCLC. Data obtained in this study will provide valuable information for planning further phase III clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.

Being tested
Carboplatin, Pemetrexed or Nab-paclitaxel, PD-1 antibody
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.

  • CarboplatinDrug

    (IV, Q3W)

  • Pemetrexed or Nab-paclitaxelDrug

    Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel (Squamous NSCLC) (IV, Q3W)

  • PD-1 antibodyDrug

    (IV, Q3W)

Study groups in NCT04422392
Study groupRoleWhat they receive
Neoadjuvant PD-1 antibody puls chemotherapyExperimentalNeoadjuvant treatment (PD-1 antibody+carboplatin+pemetrexed or nab-paclitaxel ) will start within 1-3 days from enrollment. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery. Surgery: Surgery must be done within the 4rd-6th week from day 1 cycle 3 of neoadjuvant treatment (day 29-43 after day 1 of cycle 3) Adjuvant treatment: Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 2rd to 8th week from surgery. Three cycles of combinded adjuvant treatment (PD-1 antibody+carboplatin+pemetrexed or nab-paclitaxel ) will be administered. Thirteen cycles of PD-1 antibody will start within day 21-24 days from day 1 of adjuvant cycle 2.
Receives: Drug: Carboplatin; Drug: Pemetrexed or Nab-paclitaxel; Drug: PD-1 antibody
Neoadjuvant chemotherapyActive comparatorNeoadjuvant treatment (carboplatin+pemetrexed or nab-paclitaxel ) will start within 1-3 days from enrollment/randomisation. 3 cycles will be administered at 21-day (+/- 3 days) intervals (QW3) prior to surgery. Before surgery a tumor assessment will be done. Patients must leave the study if there is evidence of progression. Patients with stable disease or partial response may be considered for surgery. Surgery: Surgery must be done within the 4rd-6th week from day 1 cycle 3 of neoadjuvant treatment (day 29-43 after day 1 of cycle 3). Adjuvant treatment: Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 2rd to 8th week from surgery. Three cycles of adjuvant treatment (carboplatin+pemetrexed or nab-paclitaxel ) will be administered.
Receives: Drug: Carboplatin; Drug: Pemetrexed or Nab-paclitaxel

What is being measured

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

  1. PFS at 24 months

    The PFS is defined as the time from diagnosis to relapse, progression or death, whichever occurred first.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Timeline

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

  1. First posted9 Jun 2020
  2. Study start13 Jul 2020
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Why it stopped: since the CheckMate816 study is published in NEJM, enrolling patients becomes difficult

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04422392
Sponsor's protocol ID
NALAN-01
Status last verified
Aug 2023
First submitted
4 Jun 2020
Last updated
30 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu L, Si H, Zhuang F, Li C, Zhang L, Zhao Y, Chen T, Dong Y, Wang T, Hou L, Hu T, Sun T, She Y, Hu X, Xie D, Wu J, Wu C, Zhao D, Chen C. Predicting therapeutic response to neoadjuvant immunotherapy based on an integration model in resectable stage IIIA (N2) non-small cell lung cancer. J Thorac Cardiovasc Surg. 2025 Jan;169(1):242-253.e4. doi: 10.1016/j.jtcvs.2024.05.006. Epub 2024 May 17.

    PubMed 38763304

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Pemetrexed or Nab-paclitaxel and PD-1 antibody in people with Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 8 sites 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 12 inclusion and 12 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 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

The study was stopped early (reason given: since the CheckMate816 study is published in NEJM, enrolling patients becomes difficult). Results are not available in the source record.

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?

PFS at 24 months (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.). 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 NCT04422392, 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 30 Aug 2023.

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