Non Small Cell Lung CancerPhase 2NEOSUNNCT04943029
Neoadjuvant Immunotherapy and Chemotherapy Followed by Surgery in Unresectable Stage Ⅲ NSCLC
A Phase 2 study testing Carrelizumab, Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) and Carboplatin in people with Non Small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery [neoadjuvant phase], followed by Camrelizumab alone after surgery [adjuvant phase] in participants with unresectable stage III non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Carrelizumab, Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2021to 1 Aug 2024
- 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
- Written informed consent provided.
- Age 18-70 when signing the consent form, both male and female;
- The ECOG score is 0 or 1;
- Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）;
- Adequate hematological function, liver function and renal function;
- Female participants should not be pregnant or breast-feeding.
Who cannot join
- EGFR mutation or ALK mutation was positive;
- Previously received systemic anti-tumor therapy for non-small cell lung cancer;
- Subjects who have received chest radiotherapy in the past;
- Known human immunodeficiency virus (HIV) infection;
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
- Pregnancy or breast-feeding women;
- Ingredients mixed with small cell lung cancer patients.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wuhan Union Hospital
Wuhan
Mingliang Wang, MD, +86 15927066167, wml6667@163.com
About this study
Official title: Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study
The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery [neoadjuvant phase], followed by Camrelizumab alone after surgery [adjuvant phase] in participants with unresectable stage III non-small cell lung cancer.
Read the detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Carrelizumab, Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC), Carboplatin, Surgery
- Keywords
- Unresectable, Stage Ⅲ NSCLC, Neoadjuvant, chemoimmunotherapy, camerlizumab, PD-1, sugery
- 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.
CarrelizumabDrug
Also called PD-1 antibody
Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.
Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)Drug
Nab-paclitaxel: 260mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles.
CarboplatinDrug
Also called chemotherapeutic drug
Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles.
SurgeryProcedure or surgery
Surgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3)
| Study group | Role | What they receive |
|---|---|---|
| PD-1+Chemo+surgery+PD-1 | Experimental | Participants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles. Receives: Drug: Carrelizumab; Drug: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC); Drug: Carboplatin; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological 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: 1 year
Secondary outcomes (4)
Resectability rate
Resectability rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.
Measured: 1 year
Percentage of incidence of adverse Events
The incidences and types of adverse events that occur during neoadjuvant therapy and perioperative period (within postoperative 30 days and 90 days) will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: approximately 16.5 months overall
PFS
Progression free survival
Measured: 2 year
OS
Overall survival
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start20 Aug 2021
- Primary completion1 May 2022 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongde Liao, PhD, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943029
- Sponsor's protocol ID
- NEOSUN
- Acronym
- NEOSUN
- Status last verified
- Jun 2021
- First submitted
- 18 Jun 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induction Therapy With Chemoimmunotherapy Followed by Surgery for Unresectable Stage III Non-small Cell Lung Cancer: a Single-center, Single-arm, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT04943029
- Acronym / sponsor ID
- NEOSUN / NEOSUN
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Unresectable, Stage Ⅲ NSCLC, Neoadjuvant, chemoimmunotherapy, camerlizumab, PD-1, sugery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 20 Aug 2021 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 29 Jun 2021 (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.
The purpose of this study is to evaluate the safety and efficacy of Camrelizumab in combination with platinum doublet neoadjuvant chemotherapy before surgery [neoadjuvant phase], followed by Camrelizumab alone after surgery [adjuvant phase] in participants with unresectable stage III non-small cell lung cancer.
Detailed description
Concurrent chemoradiotherapy is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer(NSCLC), although surgery offers the chance of cure. With combined radiation and chemotherapy, the prognosis of unresectable stage III NSCLC remains poor. Immunotherapy combined with chemotherapy has been shown to be efficacious as treatment for advanced non-squamous non-small-cell lung cancer (NSCLC) without targetable genetic aberrations. Camrelizumab, a humanised monoclonal antibody against PD-1, has shown its efficacy in the treatment of advanced NSCLC. This study is to studying neoadjuvant camrelizumab plus double platinum based chemotherapy followed by surgery to see how well it works in treating patients with unresectable stage III NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD-1+Chemo+surgery+PD-1 | Experimental | Drug: Carrelizumab, Drug: Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC), Drug: Carboplatin, Procedure: SurgeryParticipants will receive neoadjuvant Carrelizumab plus double platinum based chemotherapy for 3 cycles, followed by surgical resection and adjuvant Carrelizumab for 16 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent provided.
- Age 18-70 when signing the consent form, both male and female;
- The ECOG score is 0 or 1;
- Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology（III A-bulky N2, III B，IIIC）;
- Adequate hematological function, liver function and renal function;
Key exclusion criteria (7 listed)
- EGFR mutation or ALK mutation was positive;
- Previously received systemic anti-tumor therapy for non-small cell lung cancer;
- Subjects who have received chest radiotherapy in the past;
- Known human immunodeficiency virus (HIV) infection;
- Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease);
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 |
|---|---|---|
| CarrelizumabAlso: PD-1 antibodyCamrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles. | Drug | PD-1+Chemo+surgery+PD-1 |
| Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)Nab-paclitaxel: 260mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles. | Drug | PD-1+Chemo+surgery+PD-1 |
| CarboplatinAlso: chemotherapeutic drugCarboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles. | Drug | PD-1+Chemo+surgery+PD-1 |
| SurgerySurgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3) | Procedure or surgery | PD-1+Chemo+surgery+PD-1 |
Primary outcome
Major pathological response (MPR) rate
Time frame: 1 year
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.
4 secondary outcomes
Resectability rate
Time frame: 1 year
Percentage of incidence of adverse Events
Time frame: approximately 16.5 months overall
PFS
Time frame: 2 year
OS
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- 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.
Yongde Liao, PhD principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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 Carrelizumab, Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC) and Carboplatin in people with Non Small Cell Lung Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 6 inclusion and 7 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 2 Sep 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 Yongde Liao, PhD (+86 15972212919, liaotjxw@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR) rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2021.