A Study of Chemotherapy and Certolizumab in People Who Have Lung Cancer That Can Be Treated With Surgery

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04991025

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

8.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Lung Cancer Stage II Lung Cancer Stage III	Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine Drug: Carboplatin Drug: Certolizumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Trial of Neoadjuvant Atezolizumab + Platinum-based Chemotherapy + Certolizumab in Patients With Resectable Stages II-III Lung Cancers

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with resectable stage II-III lung cancers. This is a single arm phase II study of neoadjuvant platinum-based chemotherapy + certolizumab in participants with resectable stage II-III lung cancers. There will be separate adenocarcinoma and squamous cell carcinoma cohorts.	Drug: Cisplatin Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle. Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle. Drug: Pemetrexed Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle Drug: Gemcitabine Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle. Drug: Carboplatin Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin. Drug: Certolizumab Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.

Arm

Intervention/Treatment

Experimental: Participants with resectable stage II-III lung cancers.

This is a single arm phase II study of neoadjuvant platinum-based chemotherapy + certolizumab in participants with resectable stage II-III lung cancers. There will be separate adenocarcinoma and squamous cell carcinoma cohorts.

Drug: Cisplatin

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle. Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.

Drug: Pemetrexed

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle

Drug: Gemcitabine

Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.

Drug: Carboplatin

Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin.

Drug: Certolizumab

Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.

Outcome Measures

Primary Outcome Measures

Participants major pathologic response (MPR) [up to 2 years]
To evaluate the major pathologic response (MPR) of participants with stage II-III lung cancers who receive treatment with neoadjuvant platinum-based chemotherapy + certolizumab pegol. Major pathologic response (MPR) is defined as 10% or less residual viable tumor after neoadjuvant therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Untreated stage II-III lung cancers with operable and resectable disease determined by a thoracic surgeon
Histologic confirmation of disease at MSKCC
Age 18 years or older
Karnofsky Performance Status ≥ 70
Adequate bone marrow, liver and renal function, as specified below:
Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9 /L
Hemoglobin ≥ 8 g/dL
Platelets ≥ 100 x 10^9 /L
Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (except for patients with documented Gilbert's Syndrome)
AST and ALT ≤ 2.5 x ULN
Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal.
Negative PPD test
For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
Presence of at least one site of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors 1.1
Ability to provide written, informed consent. Legally Authorized Representatives are permitted.

Exclusion Criteria:

Presence of an FDA approved targeted therapy for patients with NSCLC harboring a genomic aberration for which an FDA-approved targeted therapy is indicated
Hypersensitivity to platinum agents
Ongoing use of investigational agents or use of investigational agents within the last four weeks
Prior use of TNF-α inhibitor
History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis
Baseline hearing deficit (CTCAE version 4.0 grade 2 or higher)
Ongoing bacterial, viral, or antifungal infection requiring antimicrobial treatment with the exception of thrush
Active tuberculosis or untreated, latent tuberculosis
If a patient has signs, symptoms, or a history suggestive of active tuberculosis, evaluation by an infectious disease physician will be required and active tuberculosis ruled-out prior to enrollment.
Acute or chronic Hepatitis B or C infection
Known HIV infection requiring antiretroviral medications and those with AIDS
Active herpes zoster infection
Non-healed infected skin ulcers
History of myocardial infarction or unstable angina within the past 12 months
Ongoing use of other immunosuppressive medications, including oral steroids and excluding topical steroids
Women who are breastfeeding
Prior history of other malignancy with the exclusion of localized prostate cancer, non-melanomatous skin cancer, ductal carcinoma or lobular carcinoma in situ of the breast

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth (Limited Protocol Activities)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York	United States	11553