Lung CancerPhase 1/2NCT05886439
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
A Phase 1/2 study testing LK101 injection (personlized neoantigen pulsed DC vaccine ), Pembrolizumab and Durvalumab in people with Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This is a open lable, single-center phase Ib/IIa study for patients with local advanced or metastastic NSCLC or ES-SCLC, who failed with previous anti-PD-1/PD-L1 therapy (cohort 1 and cohort 2) and for patients with ocal advanced or metastastic NSCLC received the first line treatment (cohort 3). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- LK101 injection (personlized neoantigen pulsed DC vaccine ), Pembrolizumab and Durvalumab
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2023to 30 May 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- signed informed consent;
- ≥18years, male or female;
- cohort1: Histologically/cytologically confirmed locally advanced or metastastic Non-small lung carcinoma (NSCLC), and received systemic treatment for recurrence/metastasis ≤3 lines; cohort2: Histologically/cytologically confirmed extensive small-cell lung carcinoma (ES-SCLC); Cohort 1 and Cohort 2 required patients progressed/recurrenced after anti-PD-1/PD-L1treatment;
- Cohort 3: Histologically/cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with no driver gene mutation and have PD-L1 expression, and who have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy.
- Life expectancy of more than 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
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- At least one measurable lesion according to RECIST 1.1;
- The sequencing of tumor were qualified;
- According to the invistigators' judgment, venous vascular conditions can meet the needs of apheresis;
- For adequate organ function, the patients need to meet the following laboratory indexes:
- hematologic functions(No blood transfusion or treatment with blood components and without granulocyte colony stimulating factor in the past 14 days.):
- the absolute value of neutrophils (ANC) ≥ 1.5x109/L;
- the platelet count was ≥ 90x109/L;
- the hemoglobin > 9g/dL;
- Hepatic functions:
- Total bilirubin ≤ 1.5 × normal upper limit (ULN); patients with liver metastasis allow ≤ 3 × ULN;
- aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastasis allow ALT or AST ≤ 5 × ULN);
- renal
- Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 50ml;
- patients with urinary protein ≥ + + and confirmed 24-hour urinary protein quantity > 1.0g;
- Coagulation function is good, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
- Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
- FBG of patients without type 2 diabetes ≤ 126 mg/dL or ≤ 7.0 mmol/L, and that of patients with type 2 diabetes ≤ 167 mg/dL or ≤ 9.3 mmol/L; Or glycosylated hemoglobin (HbA1c) ≤8%;
- If there is a risk of pregnancy, all patient (male or female) are required to take appropriate methods for contraception during the study until the 6th month post the last administration of study drug;
- Well compliance, cooperate with follow-up;
Who cannot join
- History of hypersensitivity reaction to any vaccine and/or anti-PD-1/PD-L1 formulation ingredients; Or have had a previous severe allergic reaction to other monoclonal antibodies; Subjects who had previously discontinued anti-PD-1 /PD-L1 therapy due to "infusion reaction" or immune-related AE;
- Patients who have received therapeutic tumor vaccine products (including peptide vaccine, mRNA vaccine, DC vaccine, etc.);
- Diagnosis of malignant diseases other than study disease within 5 years before screening (except for malignant tumors that can be expected to recover after treatment);
- Patients received systemic antitumor treatment within 2 weeks before the apheresis, or receive reasearch drugs or device therapy;
- Received radiotherapy within 2 weeks prior to screening;
- Toxicity caused by previous treatment did not recover to CTCAE (version 5.0) Grade 1 or below (except hair loss and peripheral neuropathy);
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- The tumor compresses the surrounding important organs or the superior vena cava, or invades the mediastinal great blood vessels, the heart, .etc;
- Patients who have recewived allogeneic hematopoietic stem cell transplantation or organ transplantation;
- A history of medical conditions that may trigger seizures (requiring treatment with antiepileptic medications);
- Patients who have active brain metastases or cancerous meningitis. Patients with treated brain metastases are eligible if they have been treated with brain metastases, and clinically stable for atleast 3 months, no evidence of disease progression 4 weeks before. All neurological symptoms had recovered, and off steroids at least 7 days prior to screening;
- Diaginosied or suspected of having an active autoimmune disease;
- patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage, or received pleural effusion or ascites treatment within the past 3 months;
- History of significant cardiovascular and cerebrovascular disease occurred in the 6 months prior to screening,Any of the following cardiac criteria:
- Mean resting corrected QT interval (QTc) > 470 ms;
- Left ventricular ejection fraction (LVEF) ≤ 50%;
- American New York heart association (NYHA) heart function ≥ 2 or higher;
- serious arrhythmia;
- poorly controlled hypertension;
- other serious heart disease;
- Patients with interstitial pneumonia, except those inactive and do not require hormone therapy disease;
- Patients diagnosed with active infections that are poorly controlled by systemic treatment;
- Any of the following test results are positive: human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA and novel coronavirus nucleic acid;
- Active tuberculosis (TB) during screening;
- Treatment with systemic steroids or other immunosuppressive agents within 14 days prior to screening;
- Vaccination within 4 weeks prior to screening;
- Major injuries and/or surgery =< 4 weeks prior to screening;
- Persons with a history of psychotropic substance abuse and inability to abstain or with a history of mental disorders;
- Pregnant or lactating women;
- Skin diseases, such as psoriasis, may prevent intradermal vaccines from reaching the target area;
- Other conditions regimented at investigators' discretion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Jie Wang, MD, 87788524 ext. 010, jiewang_hr@sina.com
About this study
Official title: A Study of LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer to Evaluate the Safety, Tolerability and Preliminary Efficacy
This is a open lable, single-center phase Ib/IIa study for patients with local advanced or metastastic NSCLC or ES-SCLC, who failed with previous anti-PD-1/PD-L1 therapy (cohort 1 and cohort 2) and for patients with ocal advanced or metastastic NSCLC received the first line treatment (cohort 3). The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab, durvalumab or tislelizumab respectively in the incurable NSCLC and SCLC.
Read the detailed description
This study is designed to evaluate the safety and efficacy of LK101 injection combined with pembrolizumab or durvalumab, which devided into 3 cohorts:
cohort 1: patients with locally advanced or metastastic (stage IIIB-IV) NSCLC who has progressed/relapsed after anti-PD-1/PD-L1 therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment.
cohort 2: patients with extensive SCLC who failed with at least first-line standard therapy with PD-L1. eligible subjects will receive LK101 injection and durvalumab treatment.
cohort 3: patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no driver gene mutation and PD-L1 expression and have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy.
LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. For the priming phase: LK101 administered once a week at Days 1, 8, 15, 22. For the booster phase: total of 3 vaccinations will be given, Q3W from the end of priming dose. Treatment can be continued according to the investigator's evaluation, subsequent treatment is administered Q6W.
Patients will receive a combination of pembrolizumab(200mg IV) Q3W in cohort 1, durvalumab (1500mg IV) Q3W in cohort 2, tislelizumab (200mg) Q3W, respectively, until disease progression (PD), intolerable toxicity.
- Conditions
- Lung Cancer
- Being tested
- LK101 injection (personlized neoantigen pulsed DC vaccine ), Pembrolizumab, Durvalumab, Tislelizumab
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LK101 injection (personlized neoantigen pulsed DC vaccine )Drug
LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations.
PembrolizumabDrug
Patients will receive pembrolizumab(200mg IV) Q3W until disease progression (PD), intolerable toxicity.
DurvalumabDrug
Patients will receive durvalumab (1500mg IV) Q3W until disease progression (PD), intolerable toxicity.
TislelizumabDrug
200 mg administered once every 3 weeks (Q3W) via intravenous infusion, with each infusion lasting longer than 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| LK101 injection combined with pembrolizumab | Experimental | patients with locally advanced or metastastic (stage IIIB-IV) NSCLC and received ≤3 lines systemtic therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment. Receives: Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ); Drug: Pembrolizumab |
| LK101 injection combined with durvalumab | Experimental | patients with extensive SCLC who failed with at least first-line standard therapy. eligible subjects will receive LK101 injection and durvalumab treatment. Receives: Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ); Drug: Durvalumab |
| LK101 injection combined with Tislelizumab | Experimental | Eligible subjects will receive LK101 injection and tislelizumab treatment. Receives: Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ); Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
incidence of Dose limited toxicity(DLT),incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); Clinically significant abnormal changes in laboratory tests and other tests.
Measured: Continuously throughout the study until 90 days after Termination of the treatment
AE
incidence and severity of adverse events
Measured: Continuously throughout the study until 90 days after Termination of the treatment
irAE
incidence and severity of immune-related adverse events
Measured: Continuously throughout the study until 90 days after Termination of the treatment
SAE
incidence and severity of serious adverse events
Measured: Continuously throughout the study until 90 days after Termination of the treatment
Secondary outcomes (8)
ORR
Objective Response Rate (ORR)according to mRECIST 1.1 standard
Measured: accessed up to 24 months from baseline
DoR
Duration of remission
Measured: 24 months
DCR
Disease Control Rate
Measured: 24 months
TTR
Time to remission
Measured: 24 months
TTP
Time to progression
Measured: 24 months
PFS
Progression Free Survival
Measured: 24 months
OS
Overall Survival
Measured: 24 months
Immune response evaluation
T cell response, cytokines, etc.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start11 May 2023
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Jie Wang, MD,PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05886439
- Sponsor's protocol ID
- LK101-IIT02
- Status last verified
- Nov 2025
- First submitted
- 6 May 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer to Evaluate the Safety, Tolerability and Preliminary Efficacy
- ClinicalTrials.gov ID
- NCT05886439
- Acronym / sponsor ID
- LK101-IIT02
- Conditions
- Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 2 Jun 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.
This is a open lable, single-center phase Ib/IIa study for patients with local advanced or metastastic NSCLC or ES-SCLC, who failed with previous anti-PD-1/PD-L1 therapy (cohort 1 and cohort 2) and for patients with ocal advanced or metastastic NSCLC received the first line treatment (cohort 3). The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab, durvalumab or tislelizumab respectively in the incurable NSCLC and SCLC.
Detailed description
This study is designed to evaluate the safety and efficacy of LK101 injection combined with pembrolizumab or durvalumab, which devided into 3 cohorts:
cohort 1: patients with locally advanced or metastastic (stage IIIB-IV) NSCLC who has progressed/relapsed after anti-PD-1/PD-L1 therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment.
cohort 2: patients with extensive SCLC who failed with at least first-line standard therapy with PD-L1. eligible subjects will receive LK101 injection and durvalumab treatment.
cohort 3: patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no driver gene mutation and PD-L1 expression and have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy.
LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. For the priming phase: LK101 administered once a week at Days 1, 8, 15, 22. For the booster phase: total of 3 vaccinations will be given, Q3W from the end of priming dose. Treatment can be continued according to the investigator's evaluation, subsequent treatment is administered Q6W.
Patients will receive a combination of pembrolizumab(200mg IV) Q3W in cohort 1, durvalumab (1500mg IV) Q3W in cohort 2, tislelizumab (200mg) Q3W, respectively, until disease progression (PD), intolerable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LK101 injection combined with pembrolizumab | Experimental | Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ), Drug: Pembrolizumabpatients with locally advanced or metastastic (stage IIIB-IV) NSCLC and received ≤3 lines systemtic therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment. |
| LK101 injection combined with durvalumab | Experimental | Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ), Drug: Durvalumabpatients with extensive SCLC who failed with at least first-line standard therapy. eligible subjects will receive LK101 injection and durvalumab treatment. |
| LK101 injection combined with Tislelizumab | Experimental | Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ), Drug: TislelizumabEligible subjects will receive LK101 injection and tislelizumab treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- signed informed consent;
- ≥18years, male or female;
- cohort1: Histologically/cytologically confirmed locally advanced or metastastic Non-small lung carcinoma (NSCLC), and received systemic treatment for recurrence/metastasis ≤3 lines; cohort2: Histologically/cytologically confirmed extensive small-cell lung carcinoma (ES-SCLC); Cohort 1 and Cohort 2 required patients progressed/recurrenced after anti-PD-1/PD-L1treatment;
- Cohort 3: Histologically/cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with no driver gene mutation and have PD-L1 expression, and who have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy.
- Life expectancy of more than 3 months;
Key exclusion criteria (30 listed)
- History of hypersensitivity reaction to any vaccine and/or anti-PD-1/PD-L1 formulation ingredients; Or have had a previous severe allergic reaction to other monoclonal antibodies; Subjects who had previously discontinued anti-PD-1 /PD-L1 therapy due to "infusion reaction" or immune-related AE;
- Patients who have received therapeutic tumor vaccine products (including peptide vaccine, mRNA vaccine, DC vaccine, etc.);
- Diagnosis of malignant diseases other than study disease within 5 years before screening (except for malignant tumors that can be expected to recover after treatment);
- Patients received systemic antitumor treatment within 2 weeks before the apheresis, or receive reasearch drugs or device therapy;
- Received radiotherapy within 2 weeks prior to screening;
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 |
|---|---|---|
| LK101 injection (personlized neoantigen pulsed DC vaccine )LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. | Drug | LK101 injection combined with Tislelizumab, LK101 injection combined with durvalumab, LK101 injection combined with pembrolizumab |
| PembrolizumabPatients will receive pembrolizumab(200mg IV) Q3W until disease progression (PD), intolerable toxicity. | Drug | LK101 injection combined with pembrolizumab |
| DurvalumabPatients will receive durvalumab (1500mg IV) Q3W until disease progression (PD), intolerable toxicity. | Drug | LK101 injection combined with durvalumab |
| Tislelizumab200 mg administered once every 3 weeks (Q3W) via intravenous infusion, with each infusion lasting longer than 30 minutes. | Drug | LK101 injection combined with Tislelizumab |
Primary outcome
DLT
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence of Dose limited toxicity(DLT),incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); Clinically significant abnormal changes in laboratory tests and other tests.
AE
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence and severity of adverse events
irAE
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence and severity of immune-related adverse events
SAE
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
incidence and severity of serious adverse events
8 secondary outcomes
ORR
Time frame: accessed up to 24 months from baseline
DoR
Time frame: 24 months
DCR
Time frame: 24 months
TTR
Time frame: 24 months
TTP
Time frame: 24 months
PFS
Time frame: 24 months
OS
Time frame: 24 months
Immune response evaluation
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- 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.
Jie Wang, MD,PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LK101 injection (personlized neoantigen pulsed DC vaccine ), Pembrolizumab and Durvalumab in people with Lung Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 25 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Wang, MD,PhD (13910704669, jiewang_hr@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Continuously throughout the study until 90 days after Termination of the treatment). The study lists 4 primary outcomes in all. 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 8 Dec 2025.