Non-Small Cell Lung Cancer (NSCLC)Phase 2NCT07885709
MRD and Imaging Guided Adaptive Neoadjuvant Therapy for Resectable NSCLC
A Phase 2 study testing PD-1 inhibitor, Carboplatin and Nab-paclitaxel in people with Non-Small Cell Lung Cancer (NSCLC), run by Peking University People's Hospital at 1 site in China.
Trial summary
Neoadjuvant immunotherapy combined with platinum-based doublet chemotherapy has been established as the standard of care for driver-gene-negative (EGFR/ALK wild-type) stage II-IIIB non-small cell lung cancer (NSCLC), yielding pathological complete response (pCR) rates of 30-40%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer (NSCLC)
- What is being tested?
- PD-1 inhibitor, Carboplatin and Nab-paclitaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2026to 1 Aug 2030
- Phase
- Phase 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
- Voluntary participation with signed informed consent.
- Previously untreated, histologically confirmed, resectable or borderline resectable stage II-IIIA or IIIB (N2) non-small cell lung cancer, per the 8th edition AJCC staging.
- Negative for EGFR and ALK driver alterations, confirmed by next-generation sequencing (NGS) or RT-PCR on tumor tissue; blood-based NGS permitted when tissue is insufficient.
- Sufficient tumor tissue for PD-L1 immunohistochemistry and NGS testing, with baseline tissue reserved for construction of a tumor-informed, fixed panel for subsequent MRD detection.
- Age ≥18 years, either sex.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
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- Adequate cardiac function with left ventricular ejection fraction (LVEF) >50%.
- Adequate pulmonary function (FEV1 >1.5 L and DLCO >50%) to tolerate definitive lung cancer resection.
- Adequate bone marrow function: white blood cell count >4×10⁹/L, neutrophil count >1.5×10⁹/L, hemoglobin >10 g/dL, and platelet count >100×10⁹/L.
- Adequate renal function with glomerular filtration rate >60 mL/min.
- Adequate hepatic function: total bilirubin <1.5× upper limit of normal (ULN), aspartate aminotransferase (AST) <3× ULN, and alanine aminotransferase (ALT) <3× ULN.
- Presence of at least one measurable lesion per RECIST 1.1.
- Women of childbearing potential must have a negative serum pregnancy test within 3 days prior to enrollment and agree to use effective contraception during study treatment and for 120 days after the last dose. Women of childbearing potential are defined as sexually mature women who (1) have not undergone hysterectomy or bilateral oophorectomy and (2) have not been naturally postmenopausal for 12 consecutive months (cancer-therapy-related amenorrhea does not preclude childbearing potential).
Who cannot join
- Active autoimmune disease or a history of autoimmune disease that may recur, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease (adequately controlled hypothyroidism on stable hormone replacement may be permitted), type 1 diabetes mellitus, multiple sclerosis, vasculitis, or glomerulonephritis.
- Active hepatitis B or C requiring antiviral therapy; patients with hepatitis B must have HBV-DNA <500 IU/mL and have received at least 14 days of anti-HBV therapy prior to enrollment, with treatment continued during the study; patients with positive HCV RNA are excluded.
- Known allergy to carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, or other chemotherapeutic agents.
- History of allergy to monoclonal antibody drugs.
- Known allergy to anlotinib or any of its excipients.
- Prior allogeneic stem cell or solid organ transplantation.
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- Severe or active infection requiring systemic therapy within 4 weeks prior to enrollment, including but not limited to active pulmonary tuberculosis, bacterial infection requiring intravenous antibiotics, active fungal infection, or known human immunodeficiency virus (HIV) infection (HIV antibody positive).
- Psychiatric disorders or any other condition that would preclude compliance with treatment.
- Inability or unwillingness to provide signed informed consent.
- Severe cardiovascular disease, including but not limited to: myocardial infarction, unstable angina, cerebrovascular accident (cerebral infarction or hemorrhage), or transient ischemic attack within 6 months prior to enrollment; New York Heart Association (NYHA) class ≥2 congestive heart failure; severe arrhythmia requiring medication (e.g., sustained ventricular tachycardia, or atrial fibrillation with rapid ventricular rate poorly controlled by medication); uncontrolled hypertension (systolic ≥150 mmHg and/or diastolic ≥95 mmHg) despite standard antihypertensive treatment; congenital long QT syndrome, or prolonged Fridericia-corrected QT interval (QTcF) on screening (males >450 ms, females >470 ms).
- Clinically significant bleeding risk or coagulation abnormality, including: known bleeding diathesis (e.g., hemophilia, von Willebrand disease) or hereditary coagulation disorders; grade ≥2 hemoptysis (single episode ≥2.5 mL) or grade ≥3 bleeding at other sites within 3 months prior to enrollment; clinically significant gastrointestinal bleeding within 4 weeks prior to enrollment; ongoing full-dose anticoagulation (e.g., warfarin, heparins, direct oral anticoagulants) that cannot be suspended or bridged to low-molecular-weight heparin during the study (patients on prophylactic low-dose anticoagulation may be eligible per investigator judgment); use of aspirin (>325 mg/day) or other platelet-inhibiting nonsteroidal anti-inflammatory drugs (NSAIDs) within 10 days prior to enrollment; imaging showing tumor invasion of or proximity to a major vessel with investigator-assessed bleeding risk.
- Major surgery within 4 weeks prior to enrollment (excluding minimally invasive diagnostic procedures such as diagnostic biopsy, percutaneous lung puncture, EBUS-TBNA, or central venous catheterization), or presence of an unhealed surgical incision, ulcer, or fracture.
- Pregnancy or breastfeeding.
- Prior or concurrent other malignancy (cured low-risk tumors such as basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or papillary thyroid carcinoma may be enrolled if, per investigator judgment, they do not affect efficacy or safety evaluation).
- Known active or uncontrolled interstitial lung disease (ILD) or pulmonary fibrosis, or screening imaging suggestive of ILD/non-infectious pneumonitis requiring corticosteroids, or a history of ILD/non-infectious pneumonitis requiring corticosteroid treatment.
- Receipt of a live or live-attenuated vaccine within 30 days prior to enrollment.
- Any comorbidity or other condition that, in the investigator's judgment, may affect protocol compliance or render the patient unsuitable for participation.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Kezhong Chen, +86 13488752289, mdkzchen@163.com
About this study
Official title: ctDNA-MRD and Imaging Response-Guided Adaptive Escalation of Neoadjuvant Therapy in Resectable and Borderline Resectable Non-Small Cell Lung Cancer: A Single-Arm, Proof-of-Concept Study
Neoadjuvant immunotherapy combined with platinum-based doublet chemotherapy has been established as the standard of care for driver-gene-negative (EGFR/ALK wild-type) stage II-IIIB non-small cell lung cancer (NSCLC), yielding pathological complete response (pCR) rates of 30-40%. Nevertheless, a substantial proportion of patients (approximately 60-70%) do not attain pCR, and strategies to further augment the pCR rate through treatment escalation remain an unmet clinical need. Accumulating evidence indicates that failure of ctDNA clearance and radiological stable disease (SD) following two cycles of neoadjuvant therapy are each robust predictors of unfavorable pathological response, and their combined assessment may enable accurate identification of the patient subset least likely to derive benefit from immunotherapy.
This single-arm, proof-of-concept study will enroll patients with resectable or borderline resectable, EGFR/ALK wild-type, stage II-IIIB (N2) NSCLC. All participants will initially receive two cycles of a PD-1 inhibitor (nivolumab, pembrolizumab, toripalimab, or tislelizumab) in combination with platinum-based doublet chemotherapy. Following two cycles, patients will undergo ctDNA-MRD assessment and radiological evaluation. Patients in whom ctDNA has not cleared and whose radiological response is stable disease will be assigned to the treatment-escalation group and receive an intensified regimen comprising a PD-1 inhibitor plus anlotinib plus chemotherapy for cycles 3-4, whereas all remaining patients will continue the original regimen. Upon completion of neoadjuvant therapy, patients deemed resectable by a multidisciplinary team (MDT) will proceed to definitive surgery.
The primary endpoint is the pCR rate in the treatment-escalation population. This study seeks to establish a precision escalation strategy guided by ctDNA-MRD in conjunction with imaging response, thereby providing an effective therapeutic approach for patients with NSCLC who respond poorly to immunotherapy and informing the design of subsequent confirmatory trials.
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Being tested
- PD-1 inhibitor, Carboplatin, Nab-paclitaxel, Pemetrexed, Anlotinib
- Keywords
- Non-Small Cell Lung Cancer(NSCLC), ctDNA, minimal residual disease (MRD), neoadjuvant immunotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 inhibitorDrug
Also called Nivolumab (Opdivo), Pembrolizumab (Keytruda), Toripalimab (Tuoyi), Tislelizumab (Tevimbra)
One of four PD-1 inhibitors selected per patient: nivolumab 360 mg, pembrolizumab 200 mg, toripalimab 240 mg, or tislelizumab 200 mg, administered by intravenous infusion once every 3 weeks
CarboplatinDrug
AUC 5 by intravenous infusion on day 1 of each 21-day cycle
Nab-paclitaxelDrug
100 mg/m² by intravenous infusion on days 1 and 5 of each 21-day cycle. Used for squamous histology throughout all cycles, and for non-squamous histology in the treatment-escalation group (cycles 3-4), where it replaces pemetrexed
PemetrexedDrug
500 mg/m² by intravenous infusion on day 1 of each 21-day cycle (non-squamous histology). In the treatment-escalation group, pemetrexed is replaced by nab-paclitaxel during cycles 3-4
AnlotinibDrug
12 mg orally once daily on days 1-14 of each 21-day cycle; added during cycles 3-4 in the treatment-escalation group
| Study group | Role | What they receive |
|---|---|---|
| ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy | Experimental | All participants initially receive two 21-day cycles of one PD-1 inhibitor (nivolumab, pembrolizumab, toripalimab, or tislelizumab) plus platinum-based doublet chemotherapy (nab-paclitaxel/carboplatin for squamous; pemetrexed/carboplatin for non-squamous histology). After two cycles, ctDNA-MRD testing and radiological assessment (RECIST 1.1) guide treatment: patients with ctDNA non-clearance and stable disease receive an intensified four-drug regimen (PD-1 inhibitor + anlotinib + nab-paclitaxel + carboplatin) for cycles 3-4, non-squamous patients switching from pemetrexed to nab-paclitaxel; all others (ctDNA clearance, or CR/PR) continue the original regimen. Upon completion of neoadjuvant therapy, patients deemed resectable by a multidisciplinary team undergo definitive surgery. Receives: Drug: PD-1 inhibitor; Drug: Carboplatin; Drug: Nab-paclitaxel; Drug: Pemetrexed; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response (pCR) rate in the treatment-escalation population
pCR is defined as the absence of residual viable tumor cells in the primary lung tumor and all sampled regional lymph nodes upon systematic pathological review of the surgical specimen, per the IASLC 2020 pathological evaluation criteria. The treatment-escalation population comprises patients with ctDNA non-clearance and radiological stable disease (SD) after two cycles of neoadjuvant therapy.
Measured: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
Secondary outcomes (8)
Major pathological response (MPR) rate in the treatment-escalation population
MPR is defined as ≤10% residual viable tumor cells in the primary lung tumor and regional lymph nodes upon pathological review of the surgical specimen; carcinoma in situ is excluded from the MPR calculation. The treatment-escalation population comprises patients with ctDNA non-clearance and radiological stable disease (SD) after two cycles of neoadjuvant therapy.
Measured: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
Pathological complete response (pCR) rate in the intention-to-treat (ITT) population
pCR is defined as the absence of residual viable tumor cells in the primary lung tumor and all sampled regional lymph nodes upon systematic pathological review of the surgical specimen, per the IASLC 2020 pathological evaluation criteria. The ITT population comprises all enrolled patients.
Measured: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
Major pathological response (MPR) rate in the intention-to-treat (ITT) population
MPR is defined as ≤10% residual viable tumor cells in the primary lung tumor and regional lymph nodes upon pathological review of the surgical specimen; carcinoma in situ is excluded from the MPR calculation. The ITT population comprises all enrolled patients.
Measured: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
2-year event-free survival (EFS) rate in the treatment-escalation and ITT populations
EFS is defined as the time from initiation of neoadjuvant therapy to the first occurrence of any of the following, whichever occurs first: radiological disease progression per RECIST 1.1 precluding surgery, local or distant recurrence, or death from any cause
Measured: 2 years
2-year overall survival (OS) rate in the treatment-escalation and ITT populations
OS is defined as the time from initiation of neoadjuvant therapy to death from any cause.
Measured: 2 years
Objective response rate (ORR) in the treatment-escalation and ITT populations
Assessed per RECIST 1.1. ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR).
Measured: After completion of neoadjuvant therapy (3-4 cycles; each cycle is 21 days), before definitive surgery
Disease control rate (DCR) in the treatment-escalation and ITT populations
Assessed per RECIST 1.1. DCR is defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD).
Measured: After completion of neoadjuvant therapy (3-4 cycles; each cycle is 21 days), before definitive surgery
Incidence and severity of treatment-related adverse events (TRAEs)
Adverse events graded and recorded according to NCI-CTCAE version 5.0.
Measured: From first dose through 90 days after the last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Aug 2030 (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 Cancer (NSCLC)Studies 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
- Model description
- Single-arm study with response-guided dynamic treatment stratification after two cycles
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BeOne Medicines, Nanjing Shihejiyin Technology, Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Chen KeZhong, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885709
- Sponsor's protocol ID
- 2026PHD021-001
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 21 Oct 2026
- 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 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ctDNA-MRD and Imaging Response-Guided Adaptive Escalation of Neoadjuvant Therapy in Resectable and Borderline Resectable Non-Small Cell Lung Cancer: A Single-Arm, Proof-of-Concept Study
- ClinicalTrials.gov ID
- NCT07885709
- Acronym / sponsor ID
- 2026PHD021-001
- Conditions
- Non-Small Cell Lung Cancer (NSCLC)
- Keywords
- Non-Small Cell Lung Cancer(NSCLC), ctDNA, minimal residual disease (MRD), neoadjuvant immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- BeOne Medicines, Nanjing Shihejiyin Technology, Inc., Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Aug 2030 (estimated)
- First posted
- 21 Oct 2026 (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.
Neoadjuvant immunotherapy combined with platinum-based doublet chemotherapy has been established as the standard of care for driver-gene-negative (EGFR/ALK wild-type) stage II-IIIB non-small cell lung cancer (NSCLC), yielding pathological complete response (pCR) rates of 30-40%. Nevertheless, a substantial proportion of patients (approximately 60-70%) do not attain pCR, and strategies to further augment the pCR rate through treatment escalation remain an unmet clinical need. Accumulating evidence indicates that failure of ctDNA clearance and radiological stable disease (SD) following two cycles of neoadjuvant therapy are each robust predictors of unfavorable pathological response, and their combined assessment may enable accurate identification of the patient subset least likely to derive benefit from immunotherapy.
This single-arm, proof-of-concept study will enroll patients with resectable or borderline resectable, EGFR/ALK wild-type, stage II-IIIB (N2) NSCLC. All participants will initially receive two cycles of a PD-1 inhibitor (nivolumab, pembrolizumab, toripalimab, or tislelizumab) in combination with platinum-based doublet chemotherapy. Following two cycles, patients will undergo ctDNA-MRD assessment and radiological evaluation. Patients in whom ctDNA has not cleared and whose radiological response is stable disease will be assigned to the treatment-escalation group and receive an intensified regimen comprising a PD-1 inhibitor plus anlotinib plus chemotherapy for cycles 3-4, whereas all remaining patients will continue the original regimen. Upon completion of neoadjuvant therapy, patients deemed resectable by a multidisciplinary team (MDT) will proceed to definitive surgery.
The primary endpoint is the pCR rate in the treatment-escalation population. This study seeks to establish a precision escalation strategy guided by ctDNA-MRD in conjunction with imaging response, thereby providing an effective therapeutic approach for patients with NSCLC who respond poorly to immunotherapy and informing the design of subsequent confirmatory trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm study with response-guided dynamic treatment stratification after two cycles
| Arm | Type | Receives |
|---|---|---|
| ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy | Experimental | Drug: PD-1 inhibitor, Drug: Carboplatin, Drug: Nab-paclitaxel, Drug: Pemetrexed, Drug: AnlotinibAll participants initially receive two 21-day cycles of one PD-1 inhibitor (nivolumab, pembrolizumab, toripalimab, or tislelizumab) plus platinum-based doublet chemotherapy (nab-paclitaxel/carboplatin for squamous; pemetrexed/carboplatin for non-squamous histology). After two cycles, ctDNA-MRD testing and radiological assessment (RECIST 1.1) guide treatment: patients with ctDNA non-clearance and stable disease receive an intensified four-drug regimen (PD-1 inhibitor + anlotinib + nab-paclitaxel + carboplatin) for cycles 3-4, non-squamous patients switching from pemetrexed to nab-paclitaxel; all others (ctDNA clearance, or CR/PR) continue the original regimen. Upon completion of neoadjuvant therapy, patients deemed resectable by a multidisciplinary team undergo definitive surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Voluntary participation with signed informed consent.
- Previously untreated, histologically confirmed, resectable or borderline resectable stage II-IIIA or IIIB (N2) non-small cell lung cancer, per the 8th edition AJCC staging.
- Negative for EGFR and ALK driver alterations, confirmed by next-generation sequencing (NGS) or RT-PCR on tumor tissue; blood-based NGS permitted when tissue is insufficient.
- Sufficient tumor tissue for PD-L1 immunohistochemistry and NGS testing, with baseline tissue reserved for construction of a tumor-informed, fixed panel for subsequent MRD detection.
- Age ≥18 years, either sex.
Key exclusion criteria (17 listed)
- Active autoimmune disease or a history of autoimmune disease that may recur, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease (adequately controlled hypothyroidism on stable hormone replacement may be permitted), type 1 diabetes mellitus, multiple sclerosis, vasculitis, or glomerulonephritis.
- Active hepatitis B or C requiring antiviral therapy; patients with hepatitis B must have HBV-DNA <500 IU/mL and have received at least 14 days of anti-HBV therapy prior to enrollment, with treatment continued during the study; patients with positive HCV RNA are excluded.
- Known allergy to carboplatin, paclitaxel, nab-paclitaxel, pemetrexed, or other chemotherapeutic agents.
- History of allergy to monoclonal antibody drugs.
- Known allergy to anlotinib or any of its excipients.
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 |
|---|---|---|
| PD-1 inhibitorAlso: Nivolumab (Opdivo), Pembrolizumab (Keytruda), Toripalimab (Tuoyi), Tislelizumab (Tevimbra)One of four PD-1 inhibitors selected per patient: nivolumab 360 mg, pembrolizumab 200 mg, toripalimab 240 mg, or tislelizumab 200 mg, administered by intravenous infusion once every 3 weeks | Drug | ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy |
| CarboplatinAUC 5 by intravenous infusion on day 1 of each 21-day cycle | Drug | ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy |
| Nab-paclitaxel100 mg/m² by intravenous infusion on days 1 and 5 of each 21-day cycle. Used for squamous histology throughout all cycles, and for non-squamous histology in the treatment-escalation group (cycles 3-4), where it replaces pemetrexed | Drug | ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy |
| Pemetrexed500 mg/m² by intravenous infusion on day 1 of each 21-day cycle (non-squamous histology). In the treatment-escalation group, pemetrexed is replaced by nab-paclitaxel during cycles 3-4 | Drug | ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy |
| Anlotinib12 mg orally once daily on days 1-14 of each 21-day cycle; added during cycles 3-4 in the treatment-escalation group | Drug | ctDNA-MRD and imaging-guided dynamic neoadjuvant therapy |
Primary outcome
Pathological complete response (pCR) rate in the treatment-escalation population
Time frame: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
pCR is defined as the absence of residual viable tumor cells in the primary lung tumor and all sampled regional lymph nodes upon systematic pathological review of the surgical specimen, per the IASLC 2020 pathological evaluation criteria. The treatment-escalation population comprises patients with ctDNA non-clearance and radiological stable disease (SD) after two cycles of neoadjuvant therapy.
8 secondary outcomes
Major pathological response (MPR) rate in the treatment-escalation population
Time frame: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
Pathological complete response (pCR) rate in the intention-to-treat (ITT) population
Time frame: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
Major pathological response (MPR) rate in the intention-to-treat (ITT) population
Time frame: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy
2-year event-free survival (EFS) rate in the treatment-escalation and ITT populations
Time frame: 2 years
2-year overall survival (OS) rate in the treatment-escalation and ITT populations
Time frame: 2 years
Objective response rate (ORR) in the treatment-escalation and ITT populations
Time frame: After completion of neoadjuvant therapy (3-4 cycles; each cycle is 21 days), before definitive surgery
Disease control rate (DCR) in the treatment-escalation and ITT populations
Time frame: After completion of neoadjuvant therapy (3-4 cycles; each cycle is 21 days), before definitive surgery
Incidence and severity of treatment-related adverse events (TRAEs)
Time frame: From first dose through 90 days after the last dose of study treatment
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 21 Oct 2026.
- 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.
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 PD-1 inhibitor, Carboplatin and Nab-paclitaxel in people with Non-Small Cell Lung Cancer (NSCLC), run by Peking University People's Hospital 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 13 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: opening soon, as of the sponsor's last update on 21 Oct 2026. 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?
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 Kezhong Chen (+86 13488752289, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate in the treatment-escalation population (time frame: At the time of definitive surgery, approximately 13 to 18 weeks after initiation of neoadjuvant therapy). 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 21 Oct 2026.