Clinical trial NCT04530227: Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC
Official title: A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Early Stage Non-small Cell Lung Cancer
Keywords: programmed cell death 1 (PD-1, PD1)
programmed cell death-ligand 1 (PD-L1, PDL1)
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).

Detailed description: This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.

Explore objective is potential biomarker associated with efficacy.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥18 years, male and female are not limited;
2. Patients with ECOG score of 0-1;
3. Life expectancy ≥12 weeks;
4. Patients must have histologically- or cytologically-documented NSCLC (according to 2015 WHO Classification);
5. Patients with stage I - IIA (T1-T2bN0M0, tumor size ≤ 50mm) confirmed by radiographic；and medical inoperable, unable to undergo thoracic surgery, or refusing to surgery (according to the eighth edition of TNM staging);
6. Patients with measurable target lesions according to the RECIST 1.1 standard;
7. Patients have not received prior treatment for their NSCLC, including radiotherapy, chemotherapy, surgery and target drugs;
8. Can provide tumor tissue;
9. Adequate organ and marrow function;
10. Fertile female were required to have a serum or urine pregnancy test within 72 hours before the start dose of study medication and the result has been negative;If female of childbearing potential, is willing to use adequate contraception for the course of the study through 90 days after the last dose of study medication; if male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 90 days after the last dose of study medication;
11. Provision of signed ICF.

Exclusion Criteria:

1. Known any distance metastases;
2. Patients with known EGFR gene mutation or ALK fusion mutation;
3. Patients with any active autoimmune disease or history of autoimmune disease;
4. Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C or co-infection with hepatitis B and hepatitis C;
5. Subjects requiring systemic treatment with corticosteroids (\> 10 mg / day of prednisone or its equivalent) or other immunosuppressants within 14 days prior to the first administration;
6. Patient must not have received a live, attenuated vaccine within 4 weeks prior to the first administration;
7. Any therapy for NSCLC treatment;
8. Patients with other malignant tumors in the past 5 years;
9. Patients with previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiologic pneumonia, drug-induced pneumonia and active pneumonia confirmed by imaging;
10. Patients with cardiac insufficiency;
11. Routine urine test indicated that urine protein was \>= (+ +), or 24-hour urine protein was \>= 1g, or severe liver and kidney dysfunction;
12. Patients with severe infection or fever of unknown origin \>38.5 ℃ within 4 weeks prior to the first administration;
13. Patients with known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
14. Pregnant or lactating women; those with fertility who are unwilling or unable to take effective contraceptive measures;
15. Known allergies, hypersensitivity, or intolerance to camrelizumab or its excipients or to pemetrexed or to nab-paclitaxel;
16. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results，or the patient is unlikely to comply with study procedures, restrictions, and requirements.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to approximately 3 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: up to approximately 5 years
measure: Objective response rate (ORR)
timeFrame: up to approximately 1 years
measure: Disease Control Rate (DCR)
timeFrame: up to approximately 3 years
measure: Adverse Events (AEs)
timeFrame: up to 18 months
measure: PFS at 12 months (PFS12)
timeFrame: up to maximum 12 months
measure: PFS at 24 months (PFS24)
timeFrame: up to maximum 24 months
measure: PFS at 5 years
timeFrame: up to maximum 5 years
measure: OS at 12 months (OS12)
timeFrame: up to maximum 12 months
measure: OS at 24 months (OS24)
timeFrame: up to maximum 24 months
measure: OS at 5 years
timeFrame: up to maximum 5 years
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
Study officials:
References: