Camrelizumab combined with chemotherapy for early stage lung cancer

A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

This study is testing if combining a new drug called camrelizumab with chemotherapy can help adults with early stage lung cancer live longer without their cancer getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: camrelizumab, chemotherapy, prednisone
• Locations: 1 site (Tianjin)
• Trial ID: NCT04530227 on ClinicalTrials.gov

What this trial studies

This trial evaluates the safety and efficacy of camrelizumab in combination with chemotherapy for adults with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC). Participants will receive 4-6 cycles of the combination treatment, followed by camrelizumab alone. The study aims to determine if this combination improves progression-free survival and assesses various efficacy and safety metrics. Additionally, the trial explores potential biomarkers associated with treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with medically inoperable Stage I or IIA NSCLC and measurable target lesions.

Not a fit: Patients who have received prior treatment for NSCLC or those with operable disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve progression-free survival for patients with early stage NSCLC who cannot undergo surgery.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy and chemotherapy combinations in lung cancer treatment.

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.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute and Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Changli Wang, PhD

Conditions Early Stage Non-small Cell Lung Cancer; programmed cell death 1; programmed cell death-ligand 1