Non-small Cell Lung CancerPhase 2NCT05878028
L-TIL Plus Tislelizumab for PD1 Antibody Resistant aNSCLC
A Phase 2 study testing L-TIL, Tislelizumab, Docetaxel in people with Non-small Cell Lung Cancer, run by Quanli Gao at 1 site in China.
Trial summary
The goal of this observational study is to test in advanced non-small cell lung cancer patients with negative driver gene. For these patients, PD1 antibody therapy combined with chemotherapy was the preferred regimen. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- L-TIL, Tislelizumab, Docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 16 Sep 2022to 15 Sep 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-small cell lung cancer patients diagnosed by pathological histology.
- Imaging examination showed stage IV disease.
- Non-squamous cancer patients shall be EGFR , ALK, ROS1, RET, MET negative.
- Failure from anti-PD-1 antibody treatment, including treatment ineffective or effective for a period then progress.
- The Eastern Oncology Collaboration Group (ECOG) scores 0-1.
- At least one imaging lesion can be measured, according to the standard for evaluating the effectiveness of solid tumors (RECIST 1.1).
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- Asymptomatic or stable symptoms after local treatment is allowed.
- Subjects are allowed to receive palliative radiation.
- Enough organ functions well.
- Patients have good superficial venous blood circulation, which can meet the needs of intravenous dripping.
- No other serious diseases that conflict with this study regimes (e.g. autoimmune diseases, immune deficiencies, organ transplants, chronic infections).
- For female subjects with reproductive age, the pregnancy test should be accepted within 3 days prior to the first study drug administered (day 1 of cycle 1) and the results are negative.
- In the event of a risk of conceival, all subjects (male or female) must adopt contraception at a rate of less than 1% annually for the entire treatment period up to 120 days after the last study of the drug was administered (or 180 days after the last study of the drug).
- The patient himself agrees to participate in this clinical trial, sign the Informed Consent Letter, complete the procedure, treatment, and follow-up.
Who cannot join
- Small cell lung cancer (SCLC), including mixing pathology, combined with SCLC and NSCLC.
- Accepted radiation treatment in special organ before the first drug was administered, eg: more than 30% bone marrow within 14 days.
- Diagnosed with second malignant diseases within five years.
- Participating in other clinical trial.
- Treatment with other drugs, including thymus peptide, interferon, interleukin, and so on.
- Active autoimmune diseases requires systemic treatment.
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- Receiving glucocorticoid therapy, excluding local glucocorticoids in nose, inhalation or other pathways, or any other form of immunosuppressive therapy.
- Uncontrolled chest and abdominal fluid.
- Patients have accepted organ transplantation or hematopoietic stem cell transplantation.
- Allergic to intervention drugs, including ingredients and auxiliary components. ·Incomplete recovery from the adverse events.
- Active hepatitis B or HCV infection.
- Accepted active vaccines within 30 days before the first dose.
- Women who are pregnant or breastfeeding.
- Symptomatic CNS metastasis.
- Uncontrolled active infections, eg. sepsis, mycemia, fungal hematoma.
- With serious mental disorders.
- Other conditions that the researchers believe in having potential risks which are not suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
No.127 Dongming Road
Zhengzhou, Henan, 450000
Xiaomin NA Fu, PhD, 86-0371-65587187, fuxiaomin0880@126.com
About this study
Official title: L-TIL Plus Tislelizumab as Second Line Therapy for PD-1 Inhibitor Resistant Advanced NSCLC Patients
The goal of this observational study is to test in advanced non-small cell lung cancer patients with negative driver gene. For these patients, PD1 antibody therapy combined with chemotherapy was the preferred regimen. However, there is no standard regimen for the patients who refractory from the first-line PD1 inhibitor based therapy.
The main questions they aim to answer are: 1.The efficacy of Liquid Tumor Infiltrating Lymphocytes (L-TIL) plus Tislelizumab and Docetaxel for patients failure from first line chemotherapy and PD1 inhibitor therapy. 2. The safety of L-TIL plus Tislelizumab and Docetaxel as second line therapy.
All participants will receive four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab treatment except for disease progression, intolerable toxicity, withdrawal informed consent, death and so on.
Read the detailed description
This study is one arm, single center, phase II clinical trial. The participants were diagnosed with metastatic non-small cell lung cancer but without actionable biomarkers (eg: EGFR, ALK, MET, ROS1). PD1 inhibitor and chemotherapy as first line therapy was not respond, or develop tumor progression after a response. Four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab regimen Q3W were used. Docetacxel was dosed 75mg/m2 and Tislelizumab was dosed 200mg on day 1, L-TIL cells were dosed (3-10)x10*9/m2 on day 14. Eligible patients were no less than 18 and no more than 75 years old, with adequate organ function but without active infection and autoimmune disease.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- L-TIL, Tislelizumab, Docetaxel
- Keywords
- L-TIL, PD1 antibody resistance, Tislizumab, Chemotherapy
- 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.
L-TIL, Tislelizumab, DocetaxelCombination product
Also called Liquid Tumor Infiltrating Lymphocytes
PD1 positive lymphocytes were collect, isolated, and expanded from peripheral blood, then infused back into the patient's body. Besides this, Tislelizumab and Docetaxel were used as combination therapy.
| Study group | Role | What they receive |
|---|---|---|
| L-TIL plus Tislelizumab and Docetaxel | Experimental | Tislelizumab, 200mg, ivgtt, d1, Q3W for one year L-TIL cells, （3-10）x10^9/m2, ivgtt, d14, Q3W for 4 or 6 cycles Docetacel, 75mg/m2, ivgtt, d1, Q3W for 4 cycles Receives: Combination Product: L-TIL, Tislelizumab, Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
overall response rate (including complete response and partial response)
Measured: 3 months
Secondary outcomes (3)
PFS
duration of disease stable or better
Measured: 6 months and 12 months
DCR
disease control rate (including patients who achieved complete response, partial response and stable disease)
Measured: 3 months
DOR
duration of response
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start16 Sep 2022
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2025 (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.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Quanli Gao
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Quanli Gao, Henan Cancer Hospital
- Investigators
- YanYan NA Liu, phD, Study chair, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878028
- Sponsor's protocol ID
- HenanCH L-TIL aNSCLC
- Status last verified
- May 2024
- First submitted
- 6 May 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-TIL Plus Tislelizumab as Second Line Therapy for PD-1 Inhibitor Resistant Advanced NSCLC Patients
- ClinicalTrials.gov ID
- NCT05878028
- Acronym / sponsor ID
- HenanCH L-TIL aNSCLC
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- L-TIL, PD1 antibody resistance, Tislizumab, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Quanli GaoOther government
- Study start
- 16 Sep 2022 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 26 May 2023 (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 goal of this observational study is to test in advanced non-small cell lung cancer patients with negative driver gene. For these patients, PD1 antibody therapy combined with chemotherapy was the preferred regimen. However, there is no standard regimen for the patients who refractory from the first-line PD1 inhibitor based therapy.
The main questions they aim to answer are: 1.The efficacy of Liquid Tumor Infiltrating Lymphocytes (L-TIL) plus Tislelizumab and Docetaxel for patients failure from first line chemotherapy and PD1 inhibitor therapy. 2. The safety of L-TIL plus Tislelizumab and Docetaxel as second line therapy.
All participants will receive four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab treatment except for disease progression, intolerable toxicity, withdrawal informed consent, death and so on.
Detailed description
This study is one arm, single center, phase II clinical trial. The participants were diagnosed with metastatic non-small cell lung cancer but without actionable biomarkers (eg: EGFR, ALK, MET, ROS1). PD1 inhibitor and chemotherapy as first line therapy was not respond, or develop tumor progression after a response. Four cycles of Docetaxel chemotherapy, six cycles of L-TIL cells infusion and one year of Tislelizumab regimen Q3W were used. Docetacxel was dosed 75mg/m2 and Tislelizumab was dosed 200mg on day 1, L-TIL cells were dosed (3-10)x10*9/m2 on day 14. Eligible patients were no less than 18 and no more than 75 years old, with adequate organ function but without active infection and autoimmune disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| L-TIL plus Tislelizumab and Docetaxel | Experimental | Combination Product: L-TIL, Tislelizumab, DocetaxelTislelizumab, 200mg, ivgtt, d1, Q3W for one year L-TIL cells, （3-10）x10^9/m2, ivgtt, d14, Q3W for 4 or 6 cycles Docetacel, 75mg/m2, ivgtt, d1, Q3W for 4 cycles |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Non-small cell lung cancer patients diagnosed by pathological histology.
- Imaging examination showed stage IV disease.
- Non-squamous cancer patients shall be EGFR , ALK, ROS1, RET, MET negative.
- Failure from anti-PD-1 antibody treatment, including treatment ineffective or effective for a period then progress.
- The Eastern Oncology Collaboration Group (ECOG) scores 0-1.
Key exclusion criteria (17 listed)
- Small cell lung cancer (SCLC), including mixing pathology, combined with SCLC and NSCLC.
- Accepted radiation treatment in special organ before the first drug was administered, eg: more than 30% bone marrow within 14 days.
- Diagnosed with second malignant diseases within five years.
- Participating in other clinical trial.
- Treatment with other drugs, including thymus peptide, interferon, interleukin, and so on.
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 |
|---|---|---|
| L-TIL, Tislelizumab, DocetaxelAlso: Liquid Tumor Infiltrating LymphocytesPD1 positive lymphocytes were collect, isolated, and expanded from peripheral blood, then infused back into the patient's body. Besides this, Tislelizumab and Docetaxel were used as combination therapy. | Combination product | L-TIL plus Tislelizumab and Docetaxel |
Primary outcome
ORR
Time frame: 3 months
overall response rate (including complete response and partial response)
3 secondary outcomes
PFS
Time frame: 6 months and 12 months
DCR
Time frame: 3 months
DOR
Time frame: 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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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.
YanYan NA Liu, phD study chair
Henan Cancer 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 L-TIL, Tislelizumab, Docetaxel in people with Non-small Cell Lung Cancer, run by Quanli Gao 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 14 inclusion and 17 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 May 2024. 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 Quanli NA Gao, PhD (86-0371-65587951, zlyygql@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 3 months). 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 23 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.