AzTrials
AzTrials

Lung Cancer Stage IIPhase 2NCT04108013

A Study of SHR-1210 in Combination With Carboplatin+Paclitaxel-albumin in Subjects With Resectable NSCLC

A Phase 2 study testing SHR-1210 and Carboplatin and Paclitaxel-albumin in people with Lung Cancer Stage II and PD-1 Antibody, run by Xuanwu Hospital, Beijing.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Trial summary

This study is a randomized, controlled, open-label, prospective, single-center phase II clinical study. Target population is patients with stage II and IIIA resectable non-small cell lung cancer who had not received systemic chemotherapy. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
SHR-1210 and Carboplatin and Paclitaxel-albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
No sites listed yet
Study dates
8 Oct 2019to 31 Jul 2021
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18-70 years of age.
  • ECOG performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.
  • Subjects are diagnosed with histologically or cytologically confirmed NSCLC.
  • Subjects are diagnosed with resectable stage II, stage IIIA non-small cell lung cancer.
  • Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion > 10 mm, the short diameter of CT scan of the lymph node lesions > 15 mm).
Show all 18Show fewer
  • Subjects haven't received radiotherapy, chemotherapy, surgery and targeted therapy before admission.
  • Subjects must have adequate pulmonary function for expected pneumonectomy.
  • The main organ's function is normal and it should meet the following criteria:
  • (1)Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
  • a.ANC ≥ 1.5×109/L； b.HB ≥ 90 g/L； c.PLT ≥ 100×109/L；
  • (2)Biochemical tests must meet the following criteria:
  • TBIL ≤ 1.5ULN；
  • ALT、AST≤ 2.5 ULN (If abnormal liver function is caused by liver metastasis, ALT、AST< 5ULN;
  • sCr≤1.5ULN，endogenous creatinine clearance rate≥50ml/min(Cockcroft-Gault formula);
  • (3)Blood coagulation must meet the following criteria: INR≤1.5 and APTT≤1.5 ULN；
  • 10.Women of childbearing age must undergo a serological pregnancy test within 3 days before the first dose with negative results and willing to use a medically approved and effective contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study and within three months after the last dose. For male subjects whose partners are women of childbearing age, they should be sterilized surgically or agree to use effective contraceptive methods during the study and within three months after the last dose.
  • 11.Subjects should be voluntarily participate in clinical studies and informed consent should be signed.

Who cannot join

  • Subjects have symptomatic central nervous system metastasis.
  • Subjects have a history of any active autoimmune disease or autoimmune disease including but not limited to the following: interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included. Subjects who need medical intervention with bronchodilators can not be included.
  • Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody is positive and HCV-RNA is higher than the lower detection limit of the analysis method) or co-infection with hepatitis B and hepatitis C.
  • Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
  • Subjects were vaccinated with live attenuated vaccine within 4 weeks before the first dose or during the study period.
  • Subjects has taken last systemic cytotoxic or radiotherapy treatment in the past 4 weeks or subjects are currently using other antineoplastic drugs.
Show all 15Show fewer
  • Subjects suffered from other malignant tumors in the past three years.
  • There is evidence that subjects have pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia and severe impairment of lung function.
  • Subjects have uncontrollable hypertension (systolic pressure ≥ 140 mmHg or diastolic pressure ≥ 90 mmHg), despite patients have taken the best drug treatment;
  • Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval > 450 ms for males and QTc interval < 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. Subjects with grade II or above heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmias, clinically pericardial disease, acute ischemia or abnormal active conduction system.
  • The subjects developed severe infection within 4 weeks before the first dose (such as: intravenous antibiotics, antifungal or antiviral drugs), or fever of unknown reason (>38.5 °C) before the first dose or during the first screening period.
  • History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation is known.
  • Pregnant or lactating women; Fertile subjects who are unwilling or unable to take effective contraceptive measures
  • It is known that subjects have allergic reaction, hypersensitivity reaction or intolerance to SHR-1210, paclitaxel-albumin or its excipients.
  • Investigators believe that there is any situation that could damage the subjects or cause the subjects to fail to meet or perform the research requirements.

Trial locations and contacts

No sites are listed yet.

Shuyang Yao contact

15810401496

yaoshuyang@163.com

About this study

Official title: A Randomized,Controlled,Open-label,Prospective,Single-center Study to Investigate the Neoadjuvant Therapy of SHR-1210 in Combination With Carboplatin and Paclitaxel-albumin in Combination With Carboplatin and Paclitaxel in Resectable NSCLC

This study is a randomized, controlled, open-label, prospective, single-center phase II clinical study. Target population is patients with stage II and IIIA resectable non-small cell lung cancer who had not received systemic chemotherapy. Study objective is to evaluate the major pathologic response of SHR-1210 + carboplatin + paclitaxel-albumin in subjects with resectable non-small cell lung cancer. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Read the detailed description

In this study, eligible subject will be randomized into study arm or control arm to accept study treatment. Subjects who randomized into control will have the opportunity to receive the treatment of carboplatin + paclitaxel-albumin therapy after confirmed disease progression. Treatment cycles of chemotherapy will be 2.

Being tested
SHR-1210, Carboplatin and Paclitaxel-albumin
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • SHR-1210Drug

    In the experimental group, 200mg SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip.

  • Carboplatin and Paclitaxel-albuminDrug

    In the control group, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip.

Study groups in NCT04108013
Study groupRoleWhat they receive
SHR-1210+Carboplatin+Paclitaxel-albuminExperimentalSubject will receive SHR-1210 200mg every 3 weeks, carboplatin AUC 5 on Day 1 of each 21 day, Paclitaxel-albumin 130mg/m2 on Day 1 and Day 8 of each 21 day, 2 cycles.
Receives: Drug: SHR-1210
Carboplatin+Paclitaxel-albuminActive comparatorSubject will receive carboplatin AUC 5 on Day 1 of each 21 day, Paclitaxel-albumin 130mg/m2 on Day 1 and Day 8 of each 21 day, 2 cycles.
Receives: Drug: Carboplatin and Paclitaxel-albumin

What is being measured

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

  1. Major pathologic response

    It is defined as residual tumors less than 10% after neoadjuvant chemotherapy.

    Measured: 3.5 months

Secondary outcomes (2)

  1. Objective Response Rate

    It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.

    Measured: 6.5 months

  2. Pathological complete response

    No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.

    Measured: 3.5 months

Timeline

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

  1. First posted27 Sep 2019
  2. Study start8 Oct 2019 (estimated)
  3. Primary completion31 Jul 2021 (estimated)
  4. Study completion31 Jul 2021 (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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04108013
Sponsor's protocol ID
XWh-NSCLC-NEO-IIT-SHR1210
Status last verified
Sep 2019
First submitted
26 Sep 2019
Last updated
27 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SHR-1210 and Carboplatin and Paclitaxel-albumin in people with Lung Cancer Stage II and PD-1 Antibody, run by Xuanwu Hospital, Beijing.

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 18 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: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

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 Shuyang Yao (15810401496, yaoshuyang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response (time frame: 3.5 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 NCT04108013.

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 27 Sep 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in