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Non Small Cell Lung CancerPhase 2NCT05295212

Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB

A Phase 2 study testing Atezolizumab in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aimed to evaluate the efficacy, safety, tolerability, feasibility of surgery, and incidence of preoperative and postoperative complications of atezolizumab in combination with platinum-based chemotherapy with resectable stage II-IIIB 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?
Atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
1 Feb 2023to 1 Jul 2025
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

  • Eligible subjects selected for this study must meet all of the following criteria:
  • Sign written informed consent before implementing any trial-related procedures;
  • Age ≥18 years old and ≤75 years old; No limit on the gender;
  • Previously untreated, histologically confirmed resectable stage II, IIIA, IIIB (N2) (AJCC stage VIII) NSCLC; cTNM stage can be confirmed by PET-CT or pathological biopsy; resectable stage II non-small cell lung cancer is defined as radical resection as assessed by a qualified thoracic surgeon; resectable is resectable and potentially resectable as defined by the Expert Consensus on Multidisciplinary Diagnosis and Treatment of Stage III Non-small Cell Lung Cancer (2019 version); resectable includes IIIA (N0-1), some single-station mediastinal lymph node metastases with N2 and some T4 (satellite nodules present in adjacent lobes) N1; potentially resectable includes some stage IIIA and IIIB, including single-station N2 mediastinal lymph node short diameter < 3 cm stage IIIA NSCLC, potentially resectable T3 or T4 central tumors; Solid/solid pulmonary nodules, not pure ground-glass opacity (GGO), are strongly recommended for pathological puncture verification;
  • Patients diagnosed with squamous cell carcinoma do not require genetic testing, and if they test positive for EGFR, ALK or ROS1, they are considered as exclusion criteria; if they are adenocarcinoma, they must undergo genetic testing containing at least EGFR, ALK and ROS1, and the acceptable detection method is ARMS or NGS, of which NGS is a cFDA-approved kit;
  • Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1;
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  • Twenty tissue sections (4-6 microns in thickness) should be submitted before enrollment for biomarker evaluation (tumor tissue samples must be fresh or archival samples obtained within 3 months before enrollment; fresh tissues must be biopsy specimens by hollow needle aspiration, resection or incision);
  • ECOG score 0-1;
  • Good organ function: (1) hematology: absolute neutrophil count (ANC) ≥ 1500/μL; platelets ≥ 100,000/μL; hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L; (2) kidney: serum creatinine ≤ 1.5 times ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cock-Gault formula); (3) liver: total bilirubin ≤ 1.5 × ULN or for subjects with total bilirubin levels > 1.5 × ULN, direct bilirubin is within normal limits; AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN; (4) endocrine system: thyroid stimulating hormone (TSH) is within normal limits. Note: If TSH is not within normal range at baseline, if T3 and free T4 are within normal range, then the subject can still meet the inclusion criteria; (5) Coagulation function: international normalized ratio (INR) or prothrombin time (PT), activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN, except: subjects receiving anticoagulant therapy, as long as PT or aPTT is within the proposed use range of anticoagulant drugs; (6) Cardiac function tests: baseline ECG showed no PR interval prolongation or atrioventricular block;
  • The total lung function can withstand the proposed pneumonectomy surgery according to the surgeon's assessment;
  • Women should agree to use contraceptive measures (such as intrauterine device (IUD), contraceptives or condoms) during the study and within 6 months after the end of the study; serum or urine pregnancy test is negative within 7 days before study entry, and must be non-lactating patients; men should agree to use contraceptive measures during the study and within 6 months after the end of the study period.

Who cannot join

  • Subjects who meet the following criteria cannot be selected for this study:
  • Histopathology is neuroendocrine carcinoma and sarcomatoid tumor；
  • The presence of locally advanced unresectable or metastatic disease; unresectable including stage III non-small cell lung cancer multidisciplinary diagnosis and treatment expert consensus (2019 version) defined unresectable, including partial IIIA, IIIB and all IIIC, usually including single-station N2 mediastinal lymph nodes short diameter ≥ 3 cm or multi-station lymph nodes fused into a mass (CT lymph nodes short diameter ≥ 2 cm) N2, invading the esophagus, heart, aorta, pulmonary veins T4 and all N3;
  • Subjects with known EGFR mutations or ALK, ROS1 translocations, non-squamous cell carcinoma subjects need to clarify the EGFR, ALK and ROS1 mutation status；
  • Early stage NSCLC previously treated with systemic anticancer therapy, including treatment with investigational agents；
  • History of (non-infectious) pneumonia/interstitial lung disease requiring steroid therapy, or current pneumonia/interstitial lung disease requiring steroid therapy；
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  • Known history of active tuberculosis;
  • Known active infection requiring systemic treatment;
  • Any known or suspected autoimmune disease or immunodeficiency subjects, except: patients with a history of hypothyroidism, if hormone therapy is not required, or are receiving physiological doses of hormone replacement therapy; subjects with stable type I diabetes whose blood glucose is controlled;
  • Subjects with active hepatitis B (defined as positive hepatitis B virus surface antigen [HBsAg] test results and HBV-DNA test values higher than the upper limit of normal of the laboratory of the study site) or hepatitis C (defined as positive hepatitis C virus surface antibody [HCsAb] test results and positive HCV-RNA test results during the screening period);
  • Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
  • Live vaccines within 30 days prior to the first dose. Including but not limited to the following: mumps, rubella, measles, varicella/herpes zoster (chickenpox), yellow fever, rabies, bacillus Calmette-Guerin (BCG) and typhoid vaccines (inactivated viral vaccines are allowed);
  • Have ≥ grade 2 peripheral neuropathy;
  • Previous treatment with PD-1/PD-L1 drugs or treatment with another drug targeting T cell receptor (such as CTLA-4, OX-40, etc.);
  • Patients with any severe and/or uncontrolled diseases, such as: (1) unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6 months before randomization, severe uncontrolled arrhythmia; patients with unsatisfactory blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); (2) active or uncontrolled severe infection; (3) liver diseases such as cirrhosis, decompensated liver disease, chronic active hepatitis; (4) poor control of diabetes (fasting blood glucose (FBG) > 10 mmol/L); (5) urine routine showed urine protein ≥ + +, and confirmed 24-hour urine protein > 1.0g; (6) a history of psychiatric drug abuse and can not quit or mental disorders;
  • Use of immunosuppressive drugs 2 times before the first study drug treatment, excluding topical glucocorticoids or systemic glucocorticoids no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids;
  • Pregnant or lactating women;
  • Prisoners who are unlawfully incarcerated or compulsorily detained for non-mental illness or physical (such as infectious diseases) diseases;
  • Patients with bleeding tendency (such as active gastrointestinal ulcers) or treatment with anticoagulants or vitamin K antagonists such as warfarin, heparin or its analogues;
  • History of allergy to study drug ingredients;
  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study.

Trial locations and contacts

1 site in 1 country.

Yongchang C Zhang, MD contact

+8613873123436 ext. 7+861383123436

zhangyongchang@csu.edu.cn

Nong C Yang, MD contact

+8613873123436 ext. +8613873123436

yangnong0217@163.com

China1 site, 1 recruiting

  • Hunan Cancer hospital

    Changsha, Hunan

    Yongchang Zhang, MD, +86 731 89762321, zhangyongchang@csu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Multicenter Phase II Clinical Study of Atezolizumab Combined With Platinum-based Chemotherapy as Neoadjuvant Therapy for Patients With Resectable Stage II-IIIB Driver Gene-negative Non-small Cell Lung Cancer (NSCLC)

This study aimed to evaluate the efficacy, safety, tolerability, feasibility of surgery, and incidence of preoperative and postoperative complications of atezolizumab in combination with platinum-based chemotherapy with resectable stage II-IIIB non-small cell lung cancer.

Being tested
Atezolizumab
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.

  • AtezolizumabDrug

    Pemetrexed (500mg/m2)/Paclitaxel (260mg/m2) Carboplatin (AUC=4-5) Atezolizumab(1200mg) ivgtt, every 21 days Range from 4 cycles

Study groups in NCT05295212
Study groupRoleWhat they receive
Cohort ANo interventionMRD revealed negative
Cohort BExperimentalMRD revealed positive
Receives: Drug: Atezolizumab

What is being measured

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

  1. MPR Rate

    Major pathological remissions

    Measured: 1.5 year

  2. MRD negative Rate

    Minimal residual disease rate

    Measured: 1.5 year

Secondary outcomes (5)

  1. pCR

    Defined as the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) to the total subjects

    Measured: 1.5 year

  2. DFS

    disease-free survival

    Measured: 1.5 year

  3. EFS

    event-free survival

    Measured: 1.5 year

  4. ORR

    Overal response rat

    Measured: 1.5 year

  5. OS

    Overall survival time

    Measured: 1.5 year

Timeline

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

  1. First posted25 Mar 2022
  2. Study start1 Feb 2023
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Jul 2025 (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
Parallel groups
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05295212
Sponsor's protocol ID
NATAL
Status last verified
Sep 2024
First submitted
15 Mar 2022
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab in people with Non Small Cell Lung Cancer, run by Hunan Province Tumor Hospital 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 11 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongchang C Zhang, MD (+8613873123436 ext. 7+861383123436, zhangyongchang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR Rate (time frame: 1.5 year). The study lists 2 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 NCT05295212.

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 19 Sep 2024.

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