AzTrials
AzTrials

Non-Small Cell Lung CancerNCT06883136

Efficacy and Safety of Sintilimab Combined with Platinum-containing Double-agent Chemotherapy in First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer in Elderly Patients

An observational study of Non-Small Cell Lung Cancer, run by Qianfoshan Hospital at 2 sites in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

To investigate the efficacy and safety of sindilizumab combined with platinum-containing dual chemotherapy in first-line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). This study was an observational, prospective, single-arm, single-center study. Read more about this study

Who is it for?
Ages 60 to 80 years
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
Sintilimab+Cis-platinum/Carboplatin with Pemetrexed or Gemcitabine
Type of treatment
Injection or infusion
How many people
43 participants
Where
2 sitesChina
Study dates
12 Mar 2025to 29 Jun 2027
Phase
Observational
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 60 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study participants with histologically or cytologically confirmed, locally advanced or metastatic (stage IIIB, IIIC, IV) NSCLC that was inoperable and not amenable to definitive concurrent chemoradiotherapy

Who may be able to join

  • Provided written informed consent before performing any trial-related procedures;
  • Age 60-80 years old;
  • Study participants with histologically or cytologically confirmed locally advanced (IIIB-IIIC) or metastatic (stage IV) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM stage), inoperable and definitive concurrent chemoradiotherapy without previous systemic therapy;
  • No EGFR gene sensitive mutation or ALK gene fusion mutation was confirmed by histological specimens; At least one radiographic measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  • 6. Had not received any previous systemic antitumor therapy for advanced/metastatic disease. Participants who had received previous platinum-based adjuvant/neoadjuvant chemotherapy or definitive chemoradiotherapy for advanced disease were allowed if they had disease progression or relapse at least 6 months after the last dose of chemotherapy.
  • 7. Study participants with asymptomatic or symptomatic stable brain metastases after local treatment were allowed to enroll as long as the study participant met the following conditions:
Show all 17Show fewer
  • 1) measurable lesions outside the central nervous system 2) no central nervous system symptoms or worsening of symptoms for at least 2 weeks 3) no glucocorticoid treatment was required, glucocorticoid treatment was discontinued within 7 days before the first dose, or the glucocorticoid dose was stable and reduced to less than 10mg/ day prednisone (or equivalent) within 7 days before the first dose 8. Study participants were allowed to receive palliative radiation therapy 7 days before the first dose of study drug and with a return of radiotherapy-related toxicity to grade 1 or less (CTCAE5.0); 9.ECOG score 0-2; 10. Expected survival time >3 months; 11. Adequate organ function, study participants had to meet the following laboratory measures:
  • absolute neutrophil count (ANC) ≥1.5x109/L without using granulocyte colony-stimulating factor for the past 14 days;
  • platelet count ≥100×109/L without blood transfusion in the past 14 days;
  • hemoglobin >9g/dL in the absence of blood transfusion or erythropoietin use in the past 14 days;
  • Total bilirubin ≤1.5 times upper limit of normal value (ULN)
  • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 ×ULN (participants with liver metastases were allowed ALT or AST ≤5×ULN);
  • serum creatinine ≤1.5 times ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 ml/min;
  • good coagulation function, defined as INR or PT ≤1.5 times ULN;
  • Euthyroid, defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH level was outside the normal range, participants were eligible if their total T3 (or FT3) and FT4 levels were within the normal range.
  • Myocardial enzymes within the normal range (isolated laboratory abnormalities that were judged by the investigators as not clinically significant were also allowed).
  • 12. Study participants were discretionary in applying the study regimen.

Who cannot join

  • Malignant diseases other than NSCLC diagnosed within 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, and/or radical resection in situ carcinoma);
  • Are currently participating in an interventional clinical study treatment, or have received another study drug or study device within 4 weeks before the first dose;
  • Prior therapy with: Anti-pd-1, anti-PD-L1 agents or agents targeting another T-cell receptor that stimulates or coinhibits it (e.g., CTLA-4, OX-40, CD137) Such as tislelizumab, toripalimab, carrelizumab, atezolizumab, slulizumab, pembrolizumab, paiampalimab, nivolumab, duvalumab, ipilimumab, etc.
  • Received systemic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) with indications for anti-NSCLC within 2 weeks before the first dose;
  • Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressive agents) occurred within 2 years before the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) were not considered systemic therapy;
  • Presence of clinically uncontrollable pleural/peritoneal effusion (participants who did not require fluid drainage or who stopped drainage for 3 days without a significant increase in fluid volume were eligible);
Show all 27Show fewer
  • Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
  • Patients with known allergy to sintilimab, pemetrexed, gemcitabine, carboplatin, cisplatin and other active ingredients or excipients of the study drug;
  • Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia);
  • Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
  • Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory at the participating center);
  • Note: Hepatitis B study participants were eligible if they met the following criteria:
  • HBV viral load <1000 copies /ml (200 IU/ml) before the first dose, study participants should receive anti-HBV therapy throughout the study chemotherapy to avoid viral reactivation
  • Study participants with anti-HBc (+), HBsAg (-), anti-hbs (-), and HBV viral load (-) do not require prophylactic anti-HBV therapy, but close monitoring for viral reactivation is required 12. Active HCV-infected study participants with positive HCV antibodies and HCV-RNA levels above the lower limit of detection; 13. A live vaccine dose within 30 days before the first dose (cycle 1, day 1); Note: Administration of injectable inactivated virus vaccine against seasonal influenza within 30 days before the first dose is allowed; Live, attenuated, intranasal influenza vaccine was not allowed.
  • 14. The presence of any serious or uncontrolled systemic illness, such as:
  • significant rhythm, conduction or morphological abnormalities in resting ECG, such as complete left bundle branch block, ≥ Ⅱ degree heart block, ventricular arrhythmia or atrial fibrillation;
  • unstable angina, congestive heart failure, New York Heart Association (NYHA) grade ≥ 2 chronic heart failure;
  • myocardial infarction within 6 months before enrollment;
  • poor blood pressure control (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
  • patients had a history of noninfectious pneumonia requiring glucocorticoid treatment within 1 year before the first dose of glucocorticoid, or current clinically active interstitial lung disease;
  • active pulmonary tuberculosis;
  • presence of active or uncontrolled infection requiring systemic therapy;
  • presence of clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction;
  • liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;
  • poorly controlled diabetes (fasting blood glucose (FBG) > 10mmol/L);
  • Urine routine test showed urinary protein ≥++ and confirmed 24-hour urinary protein quantitation > 1.0 g;
  • participants with a psychiatric disorder who were unable to cooperate with treatment; Any medical history or evidence of illness, abnormal treatment or laboratory values, or other conditions that might interfere with the results of the trial or prevent full participation in the study were considered by the investigators to be other potential risks that might preclude participation.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites

  • Degan Lu

    Jinan, Shandong, 250014

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong, 250014

Other trials in China

About this study

To investigate the efficacy and safety of sindilizumab combined with platinum-containing dual chemotherapy in first-line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

This study was an observational, prospective, single-arm, single-center study. Specific dosing regimens are as follows:

Read more
  1. Sintilimab, 200mg, intravenous infusion on day 1 of each cycle, every 3 weeks as a cycle (Q3W), until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol; The longest treatment time of sintilimab was 24 months.
  2. Chemotherapy regimen:
  3. Pemetrexed combined with platinum regimen (non-squamous cell carcinoma) : pemetrexed 500mg/m2, intravenous infusion on day 1 of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for a total of 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance pemetrexed monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons.
  4. Gemcitabine plus platinum regimen (squamous cell carcinoma) : gemcitabine 1000mg/m2 intravenously on days 1 and 8 of each cycle, cisplatin 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance gemcitabine monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons.

Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 5.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline.

Read the detailed description

To investigate the efficacy and safety of sindilizumab combined with platinum-containing dual chemotherapy in first-line treatment of elderly patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).

This study was an observational, prospective, single-arm, single-center study. Specific dosing regimens are as follows:

  1. Sintilimab, 200mg, intravenous infusion on day 1 of each cycle, every 3 weeks as a cycle (Q3W), until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol; The longest treatment time of sintilimab was 24 months.
  2. Chemotherapy regimen:
  3. Pemetrexed combined with platinum regimen (non-squamous cell carcinoma) : pemetrexed 500mg/m2, intravenous infusion on day 1 of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for a total of 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance pemetrexed monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons.
  4. Gemcitabine plus platinum regimen (squamous cell carcinoma) : gemcitabine 1000mg/m2 intravenously on days 1 and 8 of each cycle, cisplatin 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for 4-6 cycles. Participants who did not progress after 4 to 6 cycles received maintenance gemcitabine monotherapy at the same dose and cycle as before until disease progression, death, unacceptable toxicity, withdrawal of consent, initiation of a new antineoplastic therapy, or discontinuation for other protocol-specified reasons.

Patients are assessed for measurable disease at baseline, 6 weeks, 12 weeks after starting treatment, and every 9 weeks thereafter according to RECIST 1.1 criteria during the treatment period until disease progression or intolerable toxicity withdrawal. Following discontinuation of treatment, subjects are followed for survival status every 3 months until death. Subject safety was assessed during treatment according to NCI CTCAE Version 5.0 criteria. Subjects who experience an AE should be followed until the AE returns to baseline.

Being tested
Sintilimab+Cis-platinum/Carboplatin with Pemetrexed or Gemcitabine
Keywords
Sintilimab, Non-Small Cell Lung Cancer, Elderly population
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sintilimab+Cis-platinum/Carboplatin with Pemetrexed or GemcitabineDrug

    1. Sintilimab, 200mg, intravenous infusion on day 1 of each cycle, every 3 weeks as a cycle (Q3W), until disease progression, death, intolerable toxicity, withdrawal of informed consent, initiation of new anti-tumor therapy, or termination of treatment for other reasons specified in the protocol; The longest treatment time of sintilimab was 24 months.
    2. Chemotherapy regimen:
    3. Pemetrexed combined with platinum regimen (non-squamous cell carcinoma) : pemetrexed 500mg/m2, intravenous infusion on day 1 of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for a total of 4-6 cycles.
    4. Gemcitabine plus platinum regimen (squamous cell carcinoma) : gemcitabine 1000mg/m2 intravenously on days 1 and 8 of each cycle, cisplatin 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, every 3 weeks (Q3W) for 4-6 cycles.
Study groups in NCT06883136
Study groupRoleWhat they receive
Sintilimab in combination with chemotherapy containing platinumNot described
Receives: Drug: Sintilimab+Cis-platinum/Carboplatin with Pemetrexed or Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Objective Response Rate

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]

Secondary outcomes (4)

  1. PFS

    Progression-free survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  2. OS

    overall survival

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  3. DCR

    Disease Control Rate

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

  4. DoR

    Duration of Response,

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2025
  2. Study start12 Mar 2025 (estimated)
  3. Primary completion30 May 2026 (estimated)
  4. Study completion29 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
43 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06883136
Sponsor's protocol ID
YXLL-KY-2024(127)
Status last verified
Oct 2024
First submitted
12 Mar 2025
Last updated
19 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Non-Small Cell Lung Cancer, run by Qianfoshan Hospital at 2 sites 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 17 inclusion and 27 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: enrolling by invitation, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months]). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06883136.

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 19 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in