IIIB/IIIC/IV Lung CancerPhase 3NCT03944980
Study of Chemotherapy Combination With Autologous Cell Immunotherapy in the Advanced Lung Cancer
A Phase 3 study testing Docetaxel and PD1-T cells in people with IIIB/IIIC/IV Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial summary
This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood T-lymphocyte (PD1-T) combined with docetaxel in the second-line treatment of IIIB/IIIC/IV non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IIIB/IIIC/IV Lung Cancer
- What is being tested?
- Docetaxel and PD1-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2019to 1 Jun 2022
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who must meet all the following criteria should be selected:
- Agreeing to participate in this study and signing a written informed consent.
- Male or female,from 18 to 75 years (including 18 and 75 years).
- The life expectancy is longer than 3 months and can be followed up.
- Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
- According to RECIST 1.1 standard, the researchers evaluated the pre-test imaging to determine the progression of the disease after at least two cycles of platinum-containing double chemotherapies.
Show all 12Show fewer
- ECOG score will be 0 or 1 within 7 days before randomization.
- Within 14 days before the start of treatment, the results of laboratory test of blood routine, liver, kidney function and hormone levels must be met the following criteria:
- White blood cells: more than 3.0 × 109/L; Platelets: more than 100 × 109/L; Neutrophils: more than 1.5 × 109/L; Hemoglobin: more than 80g/L; Serum glutamate pyruvate transaminase: less than 2.5 folds of the upper normal limit (ULN); Serum glutamic-oxal (o) acetic transaminase: less than 2.5 × ULN; Serum bilirubin: less than 1.25 × ULN; Serum creatinine: less than 1.25 × ULN. Cortisol and thyroid function will be in the normal range.
- The toxicity and side effects of previous chemotherapy will must be alleviated to grade 1 or below (except hair loss).
- Female subjects must take effective contraceptive measures throughout the study period; serum or urine pregnancy test results must be negative during screening and the whole study period.
- Male subjects should take effective contraceptive measures from the beginning of treatment to within 6 months after the end of treatment.
Who cannot join
- Subjects who meet any of the following criteria could not participate in this study:
- Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.
- NSCLC that had received docetaxel treatment in the past.
- Other malignant tumors needed treatment within five years.
- Allogeneic tissue/organ transplantation.
- Participating in research drug therapy within 4 weeks before the first administration of the trial.
Show all 18Show fewer
- Systemic glucocorticoid therapy or any other form of immunosuppressive therapy (except glucocorticoid preconditioned with docetaxel) is being administered within 3 days before the first administration of the experimental therapy.
- Received anti-tumor monoclonal antibody (mAb), chemotherapy, targeted small molecule therapy or major surgery within 4 weeks before the first use of the drug; received chest radiotherapy greater than 30 Gy within 6 months before the first use of the drug; and received chest radiotherapy with 30 Gy or less within 1 month before the first use of the drug.
- Previous treatment with PD-1/PD-L1 antibodies.
- Over the past two years, patients with active autoimmune diseases requiring systemic treatment, such as the use of corticosteroids, or immunosuppressants. Substitution therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction) is not a systemic treatment.
- Patients with congenital or acquired immunodeficiency (e.g. HIV-infected persons), active hepatitis B (HBV-DNA > 10^3 copies/ml) or hepatitis C (hepatitis C antibody positive), and HCV-RNA higher than the detection limit of the analytical method.
- Subjects with active central nervous system (CNS) metastases and/or cancerous meningitis.
- Patients with active infections requiring systemic intravenous therapy.
- Mental illness or other illnesses, such as uncontrollable heart disease or pulmonary disease, diabetes, etc.
- Subjects who are known to be allergic to any of the constituents of the drug being studied.
- Subjects with a recent history of drug abuse (including alcohol) within one year.
- Compliance is poor and can not cooperate with clinical research.
- Female subjects who are pregnant or breastfeeding, or who are expected to be pregnant during the trial.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Liang Liu, MD., 86-22-23340123 ext. 3172, liangcoh@163.com
Xiubao Ren, MD. PhD., 86-22-23340123 ext. 3173, renxiubao@tjmuch.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Qian Sun, Ph.D, 86-22-23340123-6322, sunqian923@126.com
About this study
Official title: Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-Lymphocyte (PD1-T) Combined With Docetaxel in the Second-line Treatment of IIIB/IIIC/IV Non-small Cell Lung Cancer
This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood T-lymphocyte (PD1-T) combined with docetaxel in the second-line treatment of IIIB/IIIC/IV non-small cell lung cancer. Half of participants receive PD1-T combined with docetaxel, while the other half will receive docetaxel.
- Conditions
- IIIB/IIIC/IV Lung Cancer
- Being tested
- Docetaxel, PD1-T cells
- Keywords
- Effect, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Docetaxel injection
PD1-T cellsBiological
Also called PD-1 monoclonal antibody-activated peripheral blood T-lymphocyte
PD1-T cells injection
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: CIK | Experimental | Docetaxel \& PD1-T cells
Docetaxel,60mg/m2,intravenous infusion,d1; PD1-T cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. Receives: Drug: Docetaxel; Biological: PD1-T cells |
| Arm 2: Control | Active comparator | Docetaxel
Docetaxel,60mg/m2,intravenous infusion,d1; Q3W. Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS will be calculated from initiation of treatment until first progression, and patients alive in stable state will be censored at the time of last contact.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start1 Jun 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IIIB/IIIC/IV Lung CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiubao Ren, MD. PhD., Study chair, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944980
- Sponsor's protocol ID
- B2018-150-01
- Status last verified
- Apr 2019
- First submitted
- 28 Apr 2019
- Last updated
- 14 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Study of PD-1 Monoclonal Antibody-activated Autologous Peripheral Blood T-Lymphocyte (PD1-T) Combined With Docetaxel in the Second-line Treatment of IIIB/IIIC/IV Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT03944980
- Acronym / sponsor ID
- B2018-150-01
- Conditions
- IIIB/IIIC/IV Lung Cancer
- Keywords
- Effect, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 10 May 2019 (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.
This study evaluates the effect and safty of PD-1 monoclonal antibody-activated autologous peripheral blood T-lymphocyte (PD1-T) combined with docetaxel in the second-line treatment of IIIB/IIIC/IV non-small cell lung cancer. Half of participants receive PD1-T combined with docetaxel, while the other half will receive docetaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CIK | Experimental | Drug: Docetaxel, Biological: PD1-T cellsDocetaxel \& PD1-T cells Docetaxel,60mg/m2,intravenous infusion,d1; PD1-T cells, 1x10^10 (10 billion ), intravenous infusion,d14; Q3W. |
| Arm 2: Control | Active comparator | Drug: DocetaxelDocetaxel Docetaxel,60mg/m2,intravenous infusion,d1; Q3W. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Agreeing to participate in this study and signing a written informed consent.
- Male or female,from 18 to 75 years (including 18 and 75 years).
- The life expectancy is longer than 3 months and can be followed up.
- Patients with stage IIIB/IIIC/IV NSCLC were confirmed by histological /cytological and imaging examinations. According to RECIST 1.1 standard, there will be at least one measurable lesion.
- According to RECIST 1.1 standard, the researchers evaluated the pre-test imaging to determine the progression of the disease after at least two cycles of platinum-containing double chemotherapies.
Key exclusion criteria (18 listed)
- Adenocarcinoma subjects with EGFR sensitive mutation or ALK translocation; molecular detection of EGFR-sensitive mutations or ALK translocations is not required in squamous carcinoma patients.
- NSCLC that had received docetaxel treatment in the past.
- Other malignant tumors needed treatment within five years.
- Allogeneic tissue/organ transplantation.
- Participating in research drug therapy within 4 weeks before the first administration of the trial.
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 |
|---|---|---|
| DocetaxelDocetaxel injection | Drug | Arm 1: CIK, Arm 2: Control |
| PD1-T cellsAlso: PD-1 monoclonal antibody-activated peripheral blood T-lymphocytePD1-T cells injection | Biological | Arm 1: CIK |
Primary outcome
Progression-free survival
Time frame: 3 years
PFS will be calculated from initiation of treatment until first progression, and patients alive in stable state will be censored at the time of last contact.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2019.
Related trials for IIIB/IIIC/IV Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
Chemotherapy Combined With Immunotherapy Versus Immunotherapy Alone for Older Adults With Stage IIIB-IV Lung Cancer, The ACHIEVE Trial
Advanced Lung Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
Active, not recruiting
A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
Advanced Lung Carcinoma, Metastatic Malignant Female Reproductive System Neoplasm
RecruitingPhase 2
A Study to Investigate Ubamatamab With and Without Marlotamig (REGN7075) in Adult Participants With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Xiubao Ren, MD. PhD. study chair
Tianjin Medical University Cancer Institute and Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Docetaxel and PD1-T cells in people with IIIB/IIIC/IV Lung Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites 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 12 inclusion and 18 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xiubao Ren, MD. PhD. (86-22-23340123 ext. 3173, liangcoh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 3 years). 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 14 Jun 2019.