Non-small-cell Lung Cancer (NSCLC)Phase 2NCT04338620
Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable NSCLC
A Phase 2 study testing camrelizumab、albumin-bound paclitaxel and platinum and albumin-bound paclitaxel and platinum in people with Non-small-cell Lung Cancer (NSCLC), run by Tang-Du Hospital at 1 site in China.
Trial summary
Explorative study, which evaluates the effect of Camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-small-cell Lung Cancer (NSCLC)
- What is being tested?
- camrelizumab、albumin-bound paclitaxel and platinum and albumin-bound paclitaxel and platinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 7 Apr 2020to 1 Nov 2023
- 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
- Age :18 Years to 70 Years (Adult, Older Adult)
- ECOG physical score status of 0 or 1 points;
- expected survival time ≥ 12 weeks;
- Pathological diagnosis with StageIIIA-IIIB NSCLC;
- According to the eighth edition of the AJCC/UICC TNM staging system, patients was pathological diagnosed with Stage III-N2 clinically resectable NSCLC.
- Patients with at least one evaluable or measurable lesions as per RECIST version 1.1 （CT scan length and diameter of tumor lesion≥10mm，CT scan of lymph node lesion was short diameter≥15mm；）
Show all 26Show fewer
- Patients were newly diagnosed with non-small cell lung cancer, without radiotherapy, chemotherapy, surgery or molecule-targeted treatment.
- Patients must have enough cardiopulmonary function for the expected pulmonary resections for lung cancer.
- The main organ function meets the following criteria:1) blood routine:a. ANC ≥ 1.5×109/L; b. PLT ≥ 100×109/L; c. HB ≥ 90 g/L; 2) Blood biochemistry:TBIL ≤ 1.5×ULN;ALT、AST≤ 2.5×ULN;sCr≤1.5×ULN; 3) Blood coagulation: INR≤1.5×ULN and APTT≤1.5×ULN，endogenous creatinine clearance rate≥50ml/min(Cockcroft-Gault formula);
- Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study until the 3 months post the last administration of study drug. For men, (previous surgical sterilization accepted), shall agree to take appropriate methods of contraception during the study until the 3 months post the last administration of study drug;
- Patient has to voluntarily join the study and sign the Informed Consent Form for the study.
- Exclusion Criteria:The subject must be excluded from participating in the trial if the subject:
- Patients with brain metastasis
- Patients with autoimmune disease, or a history of autoimmune disease including but not limited to the following: autoimmune hepatitis, 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 cannot be included.
- Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/mL), hepatitis C (hepatitis C antibody is positive);
- Subjects with a condition requiring other immunosuppressive medications before 14 days of study drug administration firstly, not including inhaled corticosteroids or physiological doses of systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents).
- Has received a live vaccine within 4 weeks of planned start of study therapy.
- Other malignancies have been diagnosed within 3 years prior to the first use of the study drug; 8. Patients with a current or history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and severe impairment of lung function.
- Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg);
- patients with myocardial ischemia and myocardial infarction above class II (including QT interval prolongation, for man ≥ 450 ms, for woman ≥ 470 ms);
- Severe infection within 4 weeks before the first administration (such as intravenous drip of antibiotics, antifungal drugs or antiviral drugs), or fever of unknown origin (> 38.5 ℃) within 4 weeks before the first administration.
- allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
- Pregnant or nursing women; 14. Patients with a history of hypersensitivity to any of the study drugs, similar drugs, or excipients.
- Participated in other clinical trials within 4 weeks; 16. Patients with the history of drug abused or alcohol.
- The investigator believes that there are any conditions that may damage the subject or result in the subject being unable to meet or perform the research request;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
The Fourth Military Medical University Tangdu Hospital
Xi'an, Shaanxi, 710038
About this study
Official title: An Explorative Study on Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable Non-small-cell Lung Carcinoma
Explorative study, which evaluates the effect of Camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma.
Read the detailed description
This is a multicenter, randomized, open parallel controlled trial to evaluate the efficacy and safety of camrelizumab combined with albumin-bound paclitaxel and platinum versus albumin-bound paclitaxel combined with platinum in resectable stage IIIA -IIIB NSCLC (IIIB is limited toT3N2).
- Conditions
- Non-small-cell Lung Cancer (NSCLC)
- Being tested
- camrelizumab、albumin-bound paclitaxel and platinum, albumin-bound paclitaxel and platinum
- Keywords
- Camrelizumab, neoadjuvant treatment
- 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.
camrelizumab、albumin-bound paclitaxel and platinumDrug
Experimental Group：camrelizumab、albumin-bound paclitaxel and platinum. Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg on day1 of each cycle. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin
albumin-bound paclitaxel and platinumDrug
Control group：albumin-bound paclitaxel and platinum. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle.
Platinum included Cisplatin/carboplatin/Nedaplatin
| Study group | Role | What they receive |
|---|---|---|
| A: Experimental Group | Experimental | Participants receive totally 3 cycles of camrelizumab combined with albumin-bound paclitaxel and Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles. Receives: Drug: camrelizumab、albumin-bound paclitaxel and platinum |
| B: Control group | Active comparator | Participants receive totally 3 cycles of albumin-bound paclitaxel combined with Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles. Receives: Drug: albumin-bound paclitaxel and platinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR)
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
Measured: The day of the surgery
Secondary outcomes (4)
main pathology rate (MPR)
Major pathological response rate (MPR): defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment.
Measured: The day of the surgery
Objective Response Rate (ORR)
Objective response rate (ORR): defined as the proportion of patients whose tumor size shrinks to predefined values，which including cases of CR and PR. Objective tumor response will be assessed using RECIST 1.1. Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1.
Measured: pre-operation
Event-free Survival （EFS）
Event-free survival (EFS): defined as the time from the randomization to the first occurrence of disease progression or recurrence, or death (due to any cause).
Measured: Event-free survival (EFS): defined as the time from the randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 100 months
Assess adverse events
Assess all adverse events according to the NCI Common Terminology Criteria for (NCI CTCAE) v5.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start7 Apr 2020
- Primary completionNov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small-cell Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- This is a multicenter, randomized, open-label, parallel controlled trial.
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiang Tao, PhD, Principal investigator, The Fourth Military Medical University Tangdu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04338620
- Sponsor's protocol ID
- XBSX-L1-002
- Status last verified
- Mar 2023
- First submitted
- 6 Apr 2020
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lei J, Zhao J, Gong L, Ni Y, Zhou Y, Tian F, Liu H, Gu Z, Huang L, Lu Q, Wang X, Sun J, Yang E, Wang T, Zhong D, Wang J, Zhao Z, Liu Z, Wang C, Wang X, Lei G, Yan X, Jiang T. Neoadjuvant Camrelizumab Plus Platinum-Based Chemotherapy vs Chemotherapy Alone for Chinese Patients With Resectable Stage IIIA or IIIB (T3N2) Non-Small Cell Lung Cancer: The TD-FOREKNOW Randomized Clinical Trial. JAMA Oncol. 2023 Oct 1;9(10):1348-1355. doi: 10.1001/jamaoncol.2023.2751.
PubMed 37535377
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explorative Study on Camrelizumab Combined With Albumin-bound Paclitaxel and Platinum in Neoadjuvant Treatment of Resectable Non-small-cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT04338620
- Acronym / sponsor ID
- XBSX-L1-002
- Conditions
- Non-small-cell Lung Cancer (NSCLC)
- Keywords
- Camrelizumab, neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 8 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Explorative study, which evaluates the effect of Camrelizumab combined with albumin-bound paclitaxel and platinum in neoadjuvant treatment of resectable non-small-cell lung carcinoma.
Detailed description
This is a multicenter, randomized, open parallel controlled trial to evaluate the efficacy and safety of camrelizumab combined with albumin-bound paclitaxel and platinum versus albumin-bound paclitaxel combined with platinum in resectable stage IIIA -IIIB NSCLC (IIIB is limited toT3N2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a multicenter, randomized, open-label, parallel controlled trial.
| Arm | Type | Receives |
|---|---|---|
| A: Experimental Group | Experimental | Drug: camrelizumab、albumin-bound paclitaxel and platinumParticipants receive totally 3 cycles of camrelizumab combined with albumin-bound paclitaxel and Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles. |
| B: Control group | Active comparator | Drug: albumin-bound paclitaxel and platinumParticipants receive totally 3 cycles of albumin-bound paclitaxel combined with Cisplatin/carboplatin/Nedaplatin treatment during preoperative period, every 3 weeks for up to 3 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Age :18 Years to 70 Years (Adult, Older Adult)
- ECOG physical score status of 0 or 1 points;
- expected survival time ≥ 12 weeks;
- Pathological diagnosis with StageIIIA-IIIB NSCLC;
- According to the eighth edition of the AJCC/UICC TNM staging system, patients was pathological diagnosed with Stage III-N2 clinically resectable NSCLC.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| camrelizumab、albumin-bound paclitaxel and platinumExperimental Group：camrelizumab、albumin-bound paclitaxel and platinum. Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg on day1 of each cycle. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin | Drug | A: Experimental Group |
| albumin-bound paclitaxel and platinumControl group：albumin-bound paclitaxel and platinum. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Platinum included Cisplatin/carboplatin/Nedaplatin | Drug | B: Control group |
Primary outcome
pathological complete response (pCR)
Time frame: The day of the surgery
no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.
4 secondary outcomes
main pathology rate (MPR)
Time frame: The day of the surgery
Objective Response Rate (ORR)
Time frame: pre-operation
Event-free Survival （EFS）
Time frame: Event-free survival (EFS): defined as the time from the randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 100 months
Assess adverse events
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Derived from this study: PubMed 37535377Lei J, Zhao J, Gong L, Ni Y, Zhou Y, Tian F, Liu H, Gu Z, Huang L, Lu Q, Wang X, Sun J, Yang E, Wang T, Zhong D, Wang J, Zhao Z, Liu Z, Wang C, Wang X, Lei G, Yan X, Jiang T. Neoadjuvant Camrelizumab Plus Platinum-Based Chemotherapy vs Chemotherapy Alone for Chinese Patients With Resectable Stage IIIA or IIIB (T3N2) Non-Small Cell Lung Cancer: The TD-FOREKNOW Randomized Clinical Trial. JAMA Oncol. 2023 Oct 1;9(10):1348-1355. doi: 10.1001/jamaoncol.2023.2751.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Tao, PhD principal investigator
The Fourth Military Medical University Tangdu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing camrelizumab、albumin-bound paclitaxel and platinum and albumin-bound paclitaxel and platinum in people with Non-small-cell Lung Cancer (NSCLC), run by Tang-Du 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 26 inclusion and 0 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 6 Mar 2023. 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?
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?
pathological complete response (pCR) (time frame: The day of the surgery). 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 NCT04338620, 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 6 Mar 2023.