Ramucirumab Plus Pembrolizumab vs Usual Care for Treatment of Stage IV or Recurrent Non-Small Cell Lung Cancer Following Immunotherapy, Pragmatica-Lung Study

Overview

About this study

The purpose of this study is to compare the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. I

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Participants must have histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) which is stage IV or recurrent

- Participants must have received at least one line of anti-PD-1 or anti-PD-L1 therapy
for any stage of NSCLC. Anti-PD-1 or anti-PD-L1 may have been given alone or in
combination with other therapy

- Participants must have experienced disease progression (in the opinion of the treating
physician) more than (>) 84 days following initiation (cycle 1 day 1) of their most
recent anti-PD-1 or PD-L1 therapy

- Participants who received anti-PD-1 or anti-PD-L1 therapy for stage IV or recurrent
disease, must have had a best response on anti-PD-1 or anti-PD-L1 therapy of stable,
partial response or complete response (in the opinion of the treating physician)

- Participants who received neoadjuvant, adjuvant, and/or consolidation anti-PD-1 or
anti-PD-L1 therapy as their only line of anti-PD-1 or anti-PD-L1 therapy must have
experienced disease progression within (=<) 365 days from initiation (cycle 1 day 1)
of anti-PD-1 or PD-L1 therapy

- Participants must have received platinum-based chemotherapy and experienced disease
progression (in the opinion of the treating physician) during or after this regimen

- Participants with a known sensitizing mutation for which an Food and Drug
Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK,
ROS1, BRAF, RET, NTRK, KRAS, HER2 and MET sensitizing mutations), must have previously
received at least one of the approved therapy(s). Prior targeted therapy for
participants with targetable alterations is allowed if all other eligibility criteria
are also met

- Participants must be >= 18 years old

- Participants must be able to safely receive the investigational drug combination and
the investigator's choice of standard of care regimens per the current FDA approved
package insert(s), treating investigator's discretion, and institutional guidelines

- Participants must have Zubrod performance status of 0-2

Exclusion Criteria:

- Participants must not have received more than one line of anti-PD-1 or anti-PD-L1 for
stage IV or recurrent disease

- Participants must not be receiving or planning to receive another investigational
therapy during study participation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/15/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Aaron Mansfield, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Mankato, Minn.

Mayo Clinic principal investigator

Amrit Singh, M.B.B.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

La Crosse, Wis.

Mayo Clinic principal investigator

Scott Okuno, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Eau Claire, Wis.

Mayo Clinic principal investigator

Eyad Al-Hattab, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Yanyan Lou, M.D., Ph.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20563552

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