A Phase 1 interventional study of All-trans retinoic acid and Tislelizumab in EGFR-TKI-resistant Non-Small Cell Lung Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 1, Interventional, and Treatment
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Among 29 studies in Carcinoma, Non-Small-Cell Lung by Cancer Institute and Hospital, Chinese Academy of Medical Sciences — 21 open to participants now, 23 under way, 1 of them phase 3. Carcinoma, Non-Small-Cell Lung · Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Among the 29 studies in Carcinoma, Non-Small-Cell Lung by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, this one is the 16th largest by planned enrollment of the 17 interventional ones that give a count, is one of 9 that started in 2026, is one of 3 in phase 1, reaches primary completion later than 17 of the 22 other live ones, and was the 29th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →21 of the 29 studies in Carcinoma, Non-Small-Cell Lung by Cancer Institute and Hospital, Chinese Academy of Medical Sciences are open now, in 1 country. Recruiting first, the newest first:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18+
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18–75
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18+
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 3
First in 2009; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 24 is below the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 69 across the 17 interventional studies, 427 across the 12 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 394 studies on the registry; 280 are open to participants now.
9 of the studies in Carcinoma, Non-Small-Cell Lung by Cancer Institute and Hospital, Chinese Academy of Medical Sciences that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06198907Cancer Institute and Hospital, Chinese Academy of Medical SciencesGolidocitinib in Combination With Sintilimab for PD-L1 Selected Treatment Locally Advanced or Metastatic Non-Small Cell Lung Cancer(NSCLC) | 2026-12 |
| NCT07596524Cancer Institute and Hospital, Chinese Academy of Medical SciencesAnalysis of Different Second Line Treatment in Advanced NSCLC Patients Progressing After 1st Line Immune Checkpoint Inhibitor Therapy | 2026-12-31 |
| NCT07478809Cancer Institute and Hospital, Chinese Academy of Medical SciencesA Retrospective Real-World Study Based on RATIONALE-307 | 2026-12-31 |
| NCT07461727Cancer Institute and Hospital, Chinese Academy of Medical SciencesAn Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases | 2027-01-01 |
| NCT07166003Cancer Institute and Hospital, Chinese Academy of Medical SciencesEfficacy of Neoadjuvant Immunotherapy in Patients With Lung Cancer | 2027-02-02 |
Add all 9 to your calendar (.ics) → With an account.
Among the 29 studies in Carcinoma, Non-Small-Cell Lung by Cancer Institute and Hospital, Chinese Academy of Medical Sciences, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this Phase 1 clinical trial is to learn whether all-trans retinoic acid (ATRA) combined with tislelizumab is safe and tolerable in adults with EGFR-mutant non-small cell lung cancer (NSCLC). The study is for people whose cancer has worsened after treatment with a third-generation EGFR tyrosine kinase inhibitor and at least one standard systemic treatment, or who cannot tolerate or are not suitable for currently available standard treatments.
The main questions this study aims to answer are:
Researchers will also look for early signs that the combination can shrink or control the cancer and will assess how long participants live without their cancer getting worse and how long they live overall. Tumor tissue and blood samples will be studied to explore changes in the cancer and the immune system and to identify possible markers associated with treatment response or side effects.
All participants will receive ATRA and tislelizumab; there is no comparison or placebo group. Participants will:
This is a prospective, single-arm, open-label, Phase 1 dose-escalation and dose-expansion clinical trial evaluating all-trans retinoic acid (ATRA) in combination with tislelizumab in participants with advanced EGFR-mutant non-small cell lung cancer (NSCLC). The study population will include participants whose disease has progressed after a third-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) and at least one standard systemic therapy, as well as participants who are unable to tolerate or are considered unsuitable for currently available standard treatment. Participants must have no clearly available and appropriate standard targeted therapy, as determined by the investigator.
The study is designed to characterize the safety and tolerability of the combination, identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and obtain preliminary evidence of antitumor activity. The study will also explore molecular and immune changes associated with treatment response and toxicity.
Dose Escalation and Dose Expansion
A conventional 3+3 dose-escalation design will be used. Three ATRA dose levels are planned:
At each dose level, ATRA will be administered in combination with tislelizumab 200 mg by intravenous infusion once every 3 weeks. Initially, 3 participants will be enrolled at each dose level. Enrollment may be expanded to 6 participants at a dose level according to the occurrence of dose-limiting toxicities (DLTs) and the prespecified 3+3 dose-escalation rules.
After the RP2D has been selected, approximately 6 additional participants are planned to be enrolled in a dose-expansion cohort at that dose level. The expansion cohort will provide additional information on the safety, tolerability, and preliminary antitumor activity of the combination.
Approximately 15 to 24 participants are expected to be enrolled. The final sample size will depend on the number of DLTs observed and the outcome of dose escalation.
Treatment Plan and DLT Evaluation
Treatment will be administered in 21-day cycles. ATRA will be started 7 days before the first tislelizumab infusion. During this 7-day lead-in period, participants will receive ATRA alone. Beginning on Cycle 1 Day 1, participants will continue oral ATRA and receive tislelizumab 200 mg intravenously every 3 weeks.
The DLT evaluation period will consist of the 7-day ATRA lead-in period plus the first 21-day combination-treatment cycle, for a total of 28 days. Participants who complete the required DLT observation period, or who experience a DLT during that period, will be considered evaluable for DLT assessment.
Treatment may continue according to the protocol until disease progression, unacceptable toxicity, withdrawal of consent, pregnancy, loss to follow-up, initiation of another anticancer treatment, investigator determination that continued treatment is no longer in the participant's best interest, or termination of the study.
If an adverse event considered related to ATRA occurs, supportive treatment, temporary interruption, dose reduction, or permanent discontinuation of ATRA may be used according to the type, severity, duration, and recovery of the toxicity. Dose reduction of tislelizumab is not permitted. Tislelizumab may be interrupted, resumed, or permanently discontinued for immune-related or other clinically significant adverse events in accordance with applicable prescribing information, established toxicity-management guidance, and the investigator's clinical judgment.
Study Assessments
The study includes a screening period, a 7-day ATRA lead-in period, the combination-treatment period, an end-of-treatment visit, safety follow-up, and survival follow-up.
Screening assessments will generally be completed within 28 days before the first study treatment. Assessments will include medical and treatment history, physical examination, vital signs, performance status, concomitant medications, laboratory testing, electrocardiography, baseline tumor imaging, and collection of biological samples.
Safety and treatment suitability will be evaluated before treatment in each 21-day cycle. Assessments will include physical examination, vital signs, body weight, performance status, hematology and blood chemistry testing, lipid testing, concomitant medication review, adverse-event monitoring, and evaluation of adherence to oral ATRA treatment.
During the first year of treatment, tumor imaging will generally be performed every 6 weeks, with an allowed window of 7 days. After the first year, imaging may be performed every 9 weeks, with an allowed window of 7 days. Tumor response and disease progression will be assessed according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
Participants who discontinue all study treatment should complete an end-of-treatment visit within 28 days after the last study treatment, with an allowed window of 7 days, or before starting a new anticancer treatment, whichever occurs first. Adverse events, serious adverse events, and clinically significant laboratory abnormalities that have not resolved at treatment discontinuation will be followed until they return to baseline, improve to Grade 1 or lower, stabilize at a level considered acceptable by the investigator, are determined to be irreversible, or the participant begins a new anticancer treatment.
After completion of safety follow-up, survival status and information about subsequent anticancer treatment will be collected approximately every 3 months, with an allowed window of 7 days, until death, loss to follow-up, withdrawal of consent, or study termination.
Translational and Biomarker Research
Tumor tissue will be collected at baseline and, when specified by the protocol, at disease progression. Peripheral blood will be collected at baseline and at planned time points during treatment. These samples will be used to characterize tumor-associated molecular features and their changes over time.
Single-cell analyses may be used to evaluate the molecular characteristics and longitudinal changes of immune-cell populations in peripheral blood mononuclear cells, including T cells and monocyte/myeloid-cell populations. These exploratory analyses are intended to identify potential biomarkers associated with antitumor activity or treatment-related toxicity and to generate hypotheses regarding possible predictors of treatment response.
Statistical Considerations
No formal statistical hypothesis testing is planned for this Phase 1 dose-finding study. Analyses will primarily be descriptive. Safety findings and DLTs will be summarized overall and by dose level. Selection of the MTD and/or RP2D will be based on the prespecified 3+3 dose-escalation rules together with the overall available safety, tolerability, and clinical data.
Preliminary antitumor activity will be summarized descriptively. Time-to-event measures may be explored using the Kaplan-Meier method if the available data are sufficiently mature. Biomarker analyses will be exploratory and will be conducted in participants with suitable tumor tissue or peripheral blood samples and the corresponding clinical data.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive oral all-trans retinoic acid (ATRA) at the assigned dose level of 30 mg, 40 mg, or 50 mg twice daily in combination with tislelizumab 200 mg administered by intravenous infusion once every 3 weeks. ATRA will begin 7 days before the first tislelizumab infusion as an ATRA lead-in period and will then continue during the 21-day combination-treatment cycles. The dose-escalation phase will follow a conventional 3+3 design. After the recommended dose for further study has been determined, additional participants will receive the combination at that dose in a dose-expansion cohort. The dose-limiting toxicity evaluation period will include the 7-day ATRA lead-in period and the first 21-day combination-treatment cycle, for a total of 28 days. Treatment may continue until disease progression, unacceptable toxicity, withdrawal of consent, initiation of another anticancer treatment, investigator decision, or another protocol-defined discontinuation criterion.
Drug: All-trans retinoic acid · Drug: Tislelizumab
All-trans retinoic acid will be administered orally twice daily at an assigned dose level of 30 mg, 40 mg, or 50 mg. ATRA will begin 7 days before the first tislelizumab infusion and will continue during the subsequent 21-day combination-treatment cycles. Dose escalation will follow a conventional 3+3 design. After the recommended dose for further study has been determined, additional participants will receive ATRA at that dose in the dose-expansion cohort. ATRA may be interrupted, reduced, or permanently discontinued according to the type, severity, duration, and recovery of treatment-related toxicity.
Tislelizumab, a programmed cell death protein 1 (PD-1) inhibitor, will be administered at a dose of 200 mg by intravenous infusion once every 3 weeks. The first dose will be administered after the 7-day ATRA lead-in period, and tislelizumab will then be given in combination with oral ATRA during each 21-day treatment cycle. Dose reduction of tislelizumab is not permitted. Treatment may be interrupted, resumed, or permanently discontinued for immune-related or other clinically significant adverse events according to applicable prescribing information, established toxicity-management guidance, and the investigator's clinical judgment.
Incidence and Severity of Adverse Events
The number and percentage of participants who experience adverse events, serious adverse events, and treatment-related adverse events will be summarized overall and by dose level. Safety will also be evaluated using clinically significant changes in laboratory test results, vital signs, physical examinations, and other safety assessments.
Time frame: From the first dose of ATRA through the safety follow-up visit, approximately 28 days after the last dose of study treatment
Incidence of Dose-Limiting Toxicities
The number and percentage of DLT-evaluable participants who experience a dose-limiting toxicity (DLT) will be summarized by ATRA dose level. DLTs will be assessed according to the protocol-defined criteria during the 28-day DLT evaluation period.
Time frame: From the start of the 7-day ATRA lead-in period through the end of the first 21-day combination-treatment cycle, a total of 28 days
Maximum Tolerated Dose and/or Recommended Dose for Further Study
The maximum tolerated dose (MTD) and/or recommended dose for further study will be determined using the prespecified 3+3 dose-escalation rules. The determination will be based primarily on the occurrence of DLTs at each ATRA dose level, together with the overall available safety and tolerability data for ATRA in combination with tislelizumab.
Time frame: At completion of dose escalation, based primarily on DLTs observed during each participant's 28-day DLT evaluation period
Objective Response Rate
Objective response rate (ORR) is defined as the percentage of participants whose best overall response is a confirmed complete response (CR) or partial response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).
Time frame: From the first dose of study treatment until disease progression, initiation of a new anticancer treatment, death, withdrawal of consent, loss to follow-up, or study completion, whichever occurs first, assessed for up to approximately 24 months
Disease Control Rate
Disease control rate (DCR) is defined as the percentage of participants whose best overall response is a complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST v1.1.
Time frame: From the first dose of study treatment until disease progression, initiation of a new anticancer treatment, death, withdrawal of consent, loss to follow-up, or study completion, whichever occurs first, assessed for up to approximately 24 months
Progression-Free Survival
Progression-free survival (PFS) is defined as the time from the first dose of study treatment to the first documented disease progression according to RECIST v1.1 or death from any cause, whichever occurs first.
Time frame: From the first dose of study treatment until documented disease progression or death from any cause, whichever occurs first, assessed for up to approximately 24 months
Overall Survival
Overall survival (OS) is defined as the time from the first dose of study treatment to death from any cause.
Time frame: From the first dose of study treatment until death, withdrawal of consent, loss to follow-up, or study completion, assessed for up to approximately 24 months
Changes in Tumor Molecular Characteristics
Tumor tissue collected at baseline and, when available according to the protocol, at disease progression will be analyzed to characterize tumor-associated molecular features and their changes over time. Exploratory analyses may include genomic, transcriptomic, or other molecular characteristics, depending on sample availability and assay feasibility.
Time frame: At baseline and at documented disease progression, assessed for up to approximately 24 months
Changes in Peripheral Blood Immune-Cell Characteristics
Peripheral blood samples collected at baseline and at protocol-specified time points during treatment will be analyzed to characterize changes in the immune microenvironment. Single-cell analyses will be used to assess the molecular characteristics and longitudinal changes of immune-cell populations in peripheral blood mononuclear cells, including T cells and monocyte/myeloid-cell populations.
Time frame: At baseline and at protocol-specified time points during treatment, assessed for up to approximately 24 months
Association of Exploratory Biomarkers With Treatment Outcomes
Exploratory tumor tissue and peripheral blood biomarkers will be evaluated for potential associations with antitumor activity and treatment-related toxicity. Antitumor activity may include tumor response and disease control according to RECIST v1.1, while toxicity may include dose-limiting toxicities and other treatment-related adverse events.
Time frame: From baseline through disease progression, the end of study treatment, or study completion, assessed for up to approximately 24 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Oct 2028, 24 months later.
Of 226 non-industry phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 24 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Tretinoin
Carcinoma, Non-Small-Cell Lung →
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →