Lung Cancer, Non-small CellPhase 2NCT04541251

Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC

A Phase 2 study testing Camrelizumab + Nab-paclitaxel + Carboplatin in people with Lung Cancer, Non-small Cell and Artificial Intelligence, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Non-small Cell, Artificial Intelligence
What is being tested?: Camrelizumab + Nab-paclitaxel + Carboplatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 1 Aug 2020to 30 Sep 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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The patients have stage IB-IIIA NSCLC.
Patient ages are ≥ 18 years old, regardless of gender.
The patients have an ECOG ps of 0-1, with a condition suitable for surgery.
The patients have not received any anti-tumor treatment.
The patients have adequate blood function.
The patients have adequate organ function.
The patients had been using an appropriate method of contraception, and there exists a negative pregnancy test (serum or urine) for women.
The patients will give their signed informed consent.

Who cannot join

Patients who had a prior allogeneic tissue or organ transplantation.
Patients who have multiple cancers.
Patients who have any severe or uncontrolled systemic diseases.
Patients with a positive test for HIV, HBV, or HCV.
Patients with severe infection or with an infection that required antibiotic therapy.
Patients with a history of interstitial lung disease, active tuberculosis, or autoimmune disease.
Patients who have participated in any other clinical trials.
Patients who are considered ineligible by the investigator.

Trial locations and contacts

1 site in 1 country.

Herui Yao, PhD contact

18218018525

yaoherui@mail.sysu.edu.cn

Yunfang Yu, MD contact

yuyf9@mail.sysu.edu.cn

China1 site, 1 recruiting

Sun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510120
Herui Yao, PhD, +8618218018525, yaoherui@mail.sysu.edu.cn
Yunfang Yu, MD, +8618218018525, yuyf9@mail.sysu.edu.cn
Recruiting

Other trials in China

About this study

Official title: Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Patients With Stage IB-IIIA Non-small Cell Lung Cancer (NANE-LC): A Prospective, Single-arm, Multicenter, Phase II Study

This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.

Conditions: Lung Cancer, Non-small Cell, Artificial Intelligence
Being tested: Camrelizumab + Nab-paclitaxel + Carboplatin
Keywords: Non-small cell lung cancer, Neoadjuvant therapy, Immune checkpoint inhibitor, Major pathological response, Artificial intelligence
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 + Nab-paclitaxel + CarboplatinDrug
The patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery.

Study groups in NCT04541251
Study group	Role	What they receive
Camrelizumab + Nab-paclitaxel + Carboplatin	Experimental	Not described Receives: Drug: Camrelizumab + Nab-paclitaxel + Carboplatin

What is being measured

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

Major pathologic response (MPR) Rate
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.
Measured: After surgery (approximately 10 weeks)

Secondary outcomes (8)

Evaluation of the pathological complete response (pCR)
pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.
Measured: After surgery (approximately 10 weeks)
Evaluation of complete resection (R0) rate
Proportion of patients with no residual resection margin under the microscope after tumor resection
Measured: After surgery (approximately 10 weeks)
Disease free survival (DFS)
From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.
Measured: 36 months
Overall survival (OS)
From the date of participated in study to the date of death.
Measured: 36 months
Objective response rate(ORR)
The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery
Measured: approximately 9 weeks
Adverse events (AEs)
The number of participants experiencing an AE will be assessed.An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined
Measured: approximately 9 weeks
Serious adverse events (SAEs)
The number of participants experiencing an serious AE will be assessed
Measured: approximately 9 weeks
Qol Quality of Life
Quality of life asscesed by Quality of Life Questionnare-Core 30(EORTC QLQ-C30）of The European O-rganization for Reasearch and Functional Assessment of Cancer Therapy-Lung (FACT-L)
Measured: 36 months

Timeline

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

1 Aug 202030 Sep 2023

First posted9 Sep 2020
Study start1 Aug 2020
Primary completion30 Jul 2022 (estimated)
Study completion30 Sep 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 Lung Cancer, Non-small CellStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04541251
Sponsor's protocol ID: 2020-KY-061-001
Status last verified: Jun 2021
First submitted: 9 Feb 2020
Last updated: 23 Jun 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Zhou H, Lin L, Qin T, Ren W, Tan Y, Yang Q, Xu H, Xie X, Chen Y, Liu S, Li X, Li Z, Hu H, Yu Y, Yao H. Neoadjuvant camrelizumab, nab-paclitaxel, and carboplatin in patients with stage IB-IIIA non-small cell lung cancer (NANE-LC): a study protocol of prospective, single-arm, multicenter, phase II study. J Thorac Dis. 2021 Nov;13(11):6468-6475. doi: 10.21037/jtd-21-1022.
PubMed 34992825

Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Patients With Stage IB-IIIA Non-small Cell Lung Cancer (NANE-LC): A Prospective, Single-arm, Multicenter, Phase II Study
ClinicalTrials.gov ID: NCT04541251
Acronym / sponsor ID: 2020-KY-061-001
Conditions: Lung Cancer, Non-small Cell, Artificial Intelligence
Keywords: Non-small cell lung cancer, Neoadjuvant therapy, Immune checkpoint inhibitor, Major pathological response, Artificial intelligence
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Collaborators: Guangdong Provincial People's Hospital, Third Affiliated Hospital, Sun Yat-Sen University
Study start: 1 Aug 2020 (actual)
Primary completion: 30 Jul 2022 (estimated)
Study completion: 30 Sep 2023 (estimated)
First posted: 9 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Camrelizumab + Nab-paclitaxel + Carboplatin	Experimental	Drug: Camrelizumab + Nab-paclitaxel + Carboplatin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

The patients have stage IB-IIIA NSCLC.
Patient ages are ≥ 18 years old, regardless of gender.
The patients have an ECOG ps of 0-1, with a condition suitable for surgery.
The patients have not received any anti-tumor treatment.
The patients have adequate blood function.

Key exclusion criteria (8 listed)

Patients who had a prior allogeneic tissue or organ transplantation.
Patients who have multiple cancers.
Patients who have any severe or uncontrolled systemic diseases.
Patients with a positive test for HIV, HBV, or HCV.
Patients with severe infection or with an infection that required antibiotic therapy.

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 + Nab-paclitaxel + CarboplatinThe patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery.	Drug	Camrelizumab + Nab-paclitaxel + Carboplatin

Primary outcome

Major pathologic response (MPR) Rate
Time frame: After surgery (approximately 10 weeks)
MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.

8 secondary outcomes

Evaluation of the pathological complete response (pCR)
Time frame: After surgery (approximately 10 weeks)
Evaluation of complete resection (R0) rate
Time frame: After surgery (approximately 10 weeks)
Disease free survival (DFS)
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Objective response rate(ORR)
Time frame: approximately 9 weeks
Adverse events (AEs)
Time frame: approximately 9 weeks
Serious adverse events (SAEs)
Time frame: approximately 9 weeks
Qol Quality of Life
Time frame: 36 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Derived from this study: PubMed 34992825Zhou H, Lin L, Qin T, Ren W, Tan Y, Yang Q, Xu H, Xie X, Chen Y, Liu S, Li X, Li Z, Hu H, Yu Y, Yao H. Neoadjuvant camrelizumab, nab-paclitaxel, and carboplatin in patients with stage IB-IIIA non-small cell lung cancer (NANE-LC): a study protocol of prospective, single-arm, multicenter, phase II study. J Thorac Dis. 2021 Nov;13(11):6468-6475. doi: 10.21037/jtd-21-1022.
Individual participant dataSharing planned: Yes

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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.

Herui Yao, PhD contact

18218018525

yaoherui@mail.sysu.edu.cn

Yunfang Yu, MD contact

yuyf9@mail.sysu.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 inclusion and 8 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 23 Jun 2021. 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 Herui Yao, PhD (18218018525, yaoherui@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response (MPR) Rate (time frame: After surgery (approximately 10 weeks)). 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 NCT04541251, 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 23 Jun 2021.