TIL Therapy + Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer
This Phase I/II trial tests whether autologous tumor-infiltrating lymphocytes (TIL) β immune cells harvested from a patient's own tumor β combined with pembrolizumab (Keytruda) can produce measurable responses in patients with advanced or metastatic lung cancer who have exhausted standard therapies. The trial is actively recruiting at District One Hospital, Beijing. CancerFax helps eligible international patients navigate the access process.
About This Clinical Trial
Advanced or metastatic lung cancer β particularly non-small cell lung cancer (NSCLC) β that has progressed after standard therapies represents one of the most difficult clinical scenarios in oncology. Patients who have failed chemotherapy, targeted agents, and prior immunotherapy often have very few remaining options, and prognosis is poor. There is an urgent unmet need for therapies that can generate durable responses in this heavily pretreated population.
NCT06538012 is a Phase I/II study sponsored by Essen Biotech evaluating autologous tumor-infiltrating lymphocyte (TIL) therapy combined with pembrolizumab (Keytruda) in patients with advanced or metastatic refractory lung cancer. The treatment process involves surgically collecting tumor tissue from the patient, isolating and expanding TILs ex vivo over several weeks, and then reinfusing them following a non-myeloablative lymphodepletion regimen using cyclophosphamide and fludarabine. Interleukin-2 (IL-2) is administered post-infusion to sustain TIL activity, and pembrolizumab is given concurrently to prevent T-cell exhaustion via PD-1 blockade.
TIL therapy is scientifically compelling because it harnesses a patient's own tumor-reactive immune cells β T cells that have already identified and infiltrated the tumor. Unlike CAR-T cells, TILs are polyclonal and capable of recognizing multiple tumor antigens simultaneously, which may reduce immune escape. Pembrolizumab complements TIL therapy by blocking the PD-1 checkpoint, which cancer cells exploit to suppress immune responses. Their combination addresses both the supply of anti-tumor effector cells and the suppressive signals that limit their activity in the tumor microenvironment.
This approach is inspired by lifileucel (Amtagvi), the first FDA-approved TIL therapy, which demonstrated meaningful efficacy in unresectable or metastatic melanoma. The trial aims to extend this success to lung cancer β a significantly larger indication β with the primary safety endpoint measured at 6 months and efficacy endpoints including ORR, DCR, PFS, and DOR assessed over up to 36 months.
TIL therapy (lifileucel/Amtagvi) is already FDA-approved for melanoma. This trial investigates the same cellular immunotherapy approach in advanced lung cancer β a condition with greater global incidence and fewer effective late-line options.
Trial at a Glance
Key details from the ClinicalTrials.gov registry. Eligibility is determined only by the trial investigators after full record review.
Final eligibility is determined only by the trial investigators after reviewing complete medical records.
Treatment Being Studied
TIL therapy is a form of adoptive cell therapy that uses a patient's own immune cells β specifically T lymphocytes that have already entered the tumor β to fight cancer. These cells are extracted, grown in large numbers in a laboratory, and returned to the patient's body after a brief course of immune-depleting chemotherapy to give them space to expand and act.
In this trial, pembrolizumab (Keytruda) is added to the TIL infusion. Pembrolizumab blocks a checkpoint protein called PD-1, which tumors use to switch off T cells. By combining TIL infusion with PD-1 blockade, the trial aims to prevent the newly infused cells from being silenced by the tumor environment β keeping them active for longer.
How the therapy works (in simple terms)
How it is given
A tumor sample is collected via biopsy or surgical resection. The sample is used to isolate tumor-infiltrating lymphocytes (TILs) β T cells already present inside the tumor that are naturally reactive against cancer.
Isolated TILs are expanded ex vivo (outside the body) in a specialized laboratory setting. This process takes several weeks and produces billions of tumor-reactive T cells from the original sample.
Before TIL infusion, patients receive a non-myeloablative conditioning regimen of cyclophosphamide and fludarabine. This temporarily reduces the patient's existing immune cells, creating space for the infused TILs to expand and engraft.
The expanded autologous TILs are infused intravenously. These cells are genetically identical to the patient's own immune cells and carry reactivity against the patient's specific tumor antigens.
Following TIL infusion, interleukin-2 (IL-2 / aldesleukin) is administered to stimulate TIL survival and proliferation. Pembrolizumab is also given to block PD-1-mediated immune suppression and sustain TIL activity against the tumor.
Patients are closely monitored for safety and response. Tumor assessments are performed using RECIST v1.1 criteria. Follow-up continues for up to 36 months to evaluate ORR, DCR, PFS, DOR, and quality of life.
TILs bring volume and tumor-specific reactivity. Pembrolizumab keeps them from being exhausted by the PD-1/PD-L1 axis. Together they address two of the main reasons immune cells fail in advanced lung cancer.
Who This Trial May Be For
These profiles describe the types of patients this trial is designed for. They are based on the trial's published eligibility criteria and are illustrative β not a guarantee of qualification.
Patients must have histologically confirmed primary, relapsed, or metastatic lung cancer. The trial is specifically for patients who have failed standard treatment regimens or for whom no standard options remain.
Patients should have a Karnofsky score β₯ 60% or ECOG performance status of 0, 1, or 2. Patients with a performance status below this threshold are unlikely to tolerate the lymphodepletion and cell infusion process.
Patients must have a tumor region eligible for biopsy or resection, or malignant body fluid from which TILs can be isolated. This is necessary to produce the personalized TIL product.
Patients must have at least one measurable or evaluable tumor lesion for response assessment using RECIST v1.1 criteria throughout the trial.
Laboratory values must meet defined thresholds: ANC β₯ 1.5Γ10βΉ/L, platelets β₯ 100Γ10βΉ, hemoglobin β₯ 90 g/L, creatinine β€ 1.5 mg/dL, and ALT/AST β€ 3Γ ULN. These must be confirmed within 7 days before enrollment.
The trial is conducted at District One Hospital in Beijing, China. Patients β including international patients β must be willing and medically stable enough to travel to and remain in Beijing for the full treatment and initial follow-up period.
Eligibility Criteria
The following criteria are taken directly from the ClinicalTrials.gov registry (NCT06538012). Only the trial investigators can confirm eligibility after reviewing your full medical records.
check_circleInclusion Criteria β May Be Eligible
- βAge: 16 years to 90 years
- βHistologically diagnosed as primary, relapsed, or metastasized lung cancer
- βExpected lifespan of more than 3 months
- βKarnofsky β₯ 60% or ECOG score 0β2
- βFailed standard treatment regimens, or no standard treatment regimens available
- βHas tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated
- βAt least 1 evaluable tumor lesion
- βAbsolute white blood cell count β₯ 2.5Γ10βΉ/L (within 7 days prior to enrollment)
- βAbsolute neutrophil count β₯ 1.5Γ10βΉ/L
- βAbsolute lymphocyte count β₯ 0.7Γ10βΉ/L
- βPlatelet count β₯ 100Γ10βΉ
- βHemoglobin β₯ 90 g/L
- βAPTT β€ 1.5Γ ULN (unless on anticoagulant therapy within previous 3 days)
- βINR β€ 1.5Γ ULN (unless on anticoagulant therapy within previous 3 days)
- βSerum creatinine β€ 1.5 mg/dL (or β€ 132.6 ΞΌmol/L), or clearance rate β₯ 50 mL/min
- βSerum ALT/AST β€ 3Γ ULN (subjects with liver metastasis β€ 3Γ ULN)
- βTotal bilirubin β€ 1.5Γ ULN
- βNo absolute or relative contraindications to biopsy or surgery
- βPatients with child-bearing potential must use highly effective contraception from consent through 1 year after lymphodepletion
- βAll prior anti-tumor therapies (including radiotherapy, chemotherapy, biologics) must cease β₯ 28 days before TIL collection
- βAbility to understand and sign informed consent
- βWillingness to comply with follow-up visits and protocol requirements
cancelExclusion Criteria β May Not Be Eligible
- ΓRequires glucocorticoid treatment with daily prednisone > 15 mg (or equivalent), or autoimmune disease requiring immunomodulatory treatment
- ΓFEV1 < 2 L or DLCO (calibrated) < 40%
- ΓNYHA Grade III or IV congestive heart failure, or clinically significant cardiovascular anomalies
- ΓLow blood pressure, uncontrollable symptomatic coronary artery disease, or ejection fraction < 35%
- ΓSevere cardiac rhythm or conduction abnormality (e.g., ventricular arrhythmia requiring clinical intervention, 2ndβ3rd degree AV block)
- ΓHIV infection or anti-HIV antibody positive
- ΓActive HBV or HCV infection (HBsAg positive and/or anti-HCV positive)
- ΓSyphilis infection or Treponema pallidum antibody positive
- ΓSevere physical or mental disease
- ΓSystemic active infection requiring treatment, or positive blood cultures / imaging evidence of infection
- ΓTreatment within 1 month or ongoing treatment with other medicines, biologic therapy, chemotherapy, or radiotherapy
- ΓHistory of allergy to chemical or biological substances resembling cell therapy
- ΓPrior immunotherapy resulting in irAE of Grade > 3
- ΓPrevious anti-tumor treatment AEs not resolved to CTCAE 5.0 Grade 1 or below (excluding non-safety concerns such as alopecia)
- ΓPregnancy or lactation
- ΓHistory of organ transplantation, allogeneic stem cell transplantation, or renal replacement therapy
- ΓOther severe systemic diseases or other reasons considered inappropriate by investigators
Criteria here are illustrative. The trial protocol has its own detailed list. CancerFax can help organize records for review, but only the trial center can confirm participation.
Medical Records and Tests Needed for Review
To begin the eligibility review process, CancerFax will need the following documents. Please prepare these before submitting your inquiry.
How the Trial Process May Work
The TIL therapy process is more complex than standard chemotherapy or targeted therapy. It requires hospitalization and a multi-week treatment journey. Here is a general overview.
Potential Benefits
These are the scientific and practical reasons patients and their oncologists may consider this trial. Participation does not guarantee these benefits, and responses vary significantly between individuals.
TILs are derived from the patient's own tumor, meaning they carry natural reactivity to that individual's specific cancer antigens β a level of personalization that standard therapies cannot match.
TIL infusion addresses T-cell quantity; pembrolizumab addresses T-cell exhaustion via PD-1 blockade. The combination is designed to overcome two of the primary reasons immune cells fail in advanced lung cancer.
Unlike many targeted therapies or even some checkpoint inhibitor trials, this trial does not require a specific PD-L1 level, EGFR/ALK/ROS1 mutation, or TMB threshold β broadening eligibility across lung cancer subtypes.
The protocol is modeled on lifileucel (Amtagvi), the FDA-approved TIL therapy for melanoma, adapted for lung cancer by Essen Biotech β providing a scientifically grounded foundation for this approach.
As an investigational therapy, the TIL product, pembrolizumab, IL-2, and the lymphodepletion chemotherapy are typically provided by the sponsor at no direct cost to the patient within the trial protocol.
All participants receive close clinical monitoring for the 6-month primary safety endpoint and beyond, with structured follow-up extending to 36 months for efficacy and quality-of-life assessment.
TIL therapy is the foundation of the first FDA-approved cellular therapy for a solid tumor (melanoma). This trial extends that approach to lung cancer patients who have run out of standard options.
Risks and Side Effects
TIL therapy combined with lymphodepletion chemotherapy and IL-2 carries a distinct and significant risk profile. All participants receive close medical supervision throughout treatment.
The conditioning regimen causes temporary but profound immune suppression. Common effects include significant drop in blood counts (neutropenia, lymphopenia), increased infection risk, nausea, fatigue, and mucositis. Requires inpatient monitoring and supportive care.
IL-2 (aldesleukin) administered post-TIL infusion can cause capillary leak syndrome, hypotension, fever, rigors, fluid retention, and cardiovascular stress. High-dose IL-2 regimens require ICU-capable monitoring settings.
Pembrolizumab (Keytruda) blocks PD-1 and can cause immune-related adverse events (irAEs) including pneumonitis, colitis, hepatitis, endocrinopathies (hypothyroidism, adrenal insufficiency), and dermatitis. Grade β₯ 3 irAEs may require immunosuppressive therapy or discontinuation.
The period immediately following lymphodepletion and TIL infusion is characterized by severe immunosuppression, during which bacterial, fungal, and viral infections are a significant risk. Prophylactic antibiotics and antifungals are typically administered.
As with all investigational therapies, not all patients will respond. Some may experience disease progression despite treatment. The primary endpoint in Phase I is safety, not efficacy β the trial is designed to establish a safe dosing framework first.
TIL collection requires biopsy or surgical resection of tumor tissue. All surgical and interventional procedures carry risks of bleeding, infection, pain, anesthesia reactions, and β in rare cases β complications related to tumor location.
Treatment occurs across multiple phases spanning several weeks to months. International patients must plan for an extended stay in Beijing, including the TIL manufacturing waiting period, hospital admission, infusion, and initial recovery. CancerFax can assist with travel and accommodation planning.
TIL therapy involves a conditioning chemotherapy regimen, high-dose cell infusion, and IL-2 administration β all of which require inpatient management. Risks are real and must be discussed with the trial team and your own oncologist.
Trial Location and Hospital Information
NCT06538012 is currently conducted at a single site in Beijing, China, operated by Essen Biotech in collaboration with District One Hospital (also known as Beijing District One Hospital). The trial contact is Dr. SAMI XI.
β VERIFY: International patient eligibility for this trial has not been explicitly confirmed in the registry listing, but the trial is run by Essen Biotech β a sponsor with an active international patient program across their oncology portfolio. CancerFax can contact the trial team directly on your behalf to determine whether you qualify as an international participant and what logistical support is available.
Costs, Trial Coverage, and Patient Expenses
Cost coverage for clinical trial participants depends on what is considered investigational vs. standard care. The table below reflects typical coverage models for this type of adoptive cell therapy trial. Confirm specifics with the trial team.
In most Phase I/II sponsored trials, the investigational therapy β here including the TIL product, pembrolizumab, IL-2, and lymphodepletion chemotherapy β is provided by the sponsor. Travel, accommodation, and personal costs are not covered. CancerFax can provide guidance on financial planning for international patients.
Standard Treatment vs Clinical Trial
This comparison is educational. It is not a recommendation to choose the trial over standard care. Decisions should be made with your oncologist after reviewing your individual clinical situation.
How CancerFax Supports You
CancerFax is a global cancer navigation platform. We help patients and families understand advanced treatment options and access trials like this one through structured support β not direct enrollment.
Our medical team reviews your pathology reports, imaging, prior treatment history, and bloodwork to assess whether you meet the published eligibility criteria before approaching the trial center.
We map your records against the trial's inclusion and exclusion criteria and give you an honest, clear-eyed assessment of your likely eligibility β so you don't travel to Beijing without a realistic basis.
CancerFax contacts the investigator team at District One Hospital on your behalf, submits your summary records, and facilitates the initial medical dialogue. We handle language and logistics so you can focus on health.
We provide practical support for international patients planning to travel to Beijing: visa guidance, accommodation recommendations near the trial site, interpreter coordination, and arrival logistics.
If you are not eligible for this specific trial, CancerFax can identify similar TIL therapy, immunotherapy, or other advanced lung cancer trials globally β including other Essen Biotech studies and international options.
From your first inquiry to post-treatment follow-up support, CancerFax provides coordinated, human-led navigation. We do not replace your oncologist β we help you access specialist pathways they may not have direct connections to.
CancerFax does not guarantee trial enrollment, treatment response, or outcome. Our role is to help patients access accurate information and appropriate pathways.
Questions to Ask Before Considering This Trial
If you speak with the investigators or your oncologist about this trial, these questions will help you make an informed decision.
Frequently Asked Questions
Ready to Explore This Trial?
CancerFax helps advanced lung cancer patients and families understand whether this trial may be an appropriate option β and navigate the access process if so. Submit your case for a no-obligation medical review.
The information on this page is for educational and patient-navigation purposes only. It does not replace medical advice, diagnosis, or treatment from a qualified physician. Clinical trial eligibility, enrollment, treatment decisions, and costs are determined only by the trial investigators, hospital, sponsor, and applicable regulations. CancerFax helps patients and families understand options and coordinate case review where appropriate, but does not guarantee trial acceptance, treatment response, or clinical outcome. All clinical decisions must be made in consultation with a qualified, licensed physician with access to the patient's complete medical information.
Related Pages on CancerFax
Β© CancerFax Β· Specialist cancer access and patient-navigation platform. CancerFax is not a medical institution, hospital, or clinical trial sponsor. Trial details may change; always confirm current eligibility, status, and costs directly with the trial center.