A Study to Learn About the Study Medicine PF-07934040 When Given Alone or With Other Anti-cancer Therapies in People With Advanced Solid Tumors That Have a Genetic Mutation.

A Phase 1 Open-Label Study of PF-07934040 as a Single Agent and in Combination With Other Targeted Agents in Participants With Advanced Solid Tumors Harboring Mutations in the KRAS Gene

The purpose of this study is to learn about the safety and effects of the study medicine alone or when given together with other anti-cancer therapies. This study also aims to find the best dose.

This study is seeking participants who have solid tumors (a mass of abnormal cells that forms a lump or growth in the body) that:

• are advanced (cancer that doesn't disappear or stay away with treatment) and
• have a KRAS gene mutation (a change in the DNA of the KRAS gene that can cause cells to grow in very high numbers).

This includes (but limited to) the following cancer types:

Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body.

Colorectal Cancer (CRC): This is a disease where cells in the colon (a part of large intestine) or rectum grow out of control.

Pancreatic ductal adenocarcinoma (PDAC): This is a cancer that starts in the ducts of the pancreas but can spread quickly to other parts of the body. Pancreas is a long, flat gland that lies in the abdomen behind the stomach. Pancreas creates enzymes that help with digestion. It also makes hormones that can help control your blood sugar levels.

All participants in this study will take the study medication (PF-07934040) as pill by mouth twice a day repeating for 21-day or 28-day cycles.

Depending on which part of the study participants are enrolled into they will receive the study medication (PF-07934040 alone or in combination with other anti-cancer medications). These anti-cancer medications will be given in the study clinic by intravenous (IV) that is directly injected into the veins at various times (depending on the treatment) during the 21-day or 28-day cycle.

Participants can continue to take the study medication (PF-07934040) and the combination anti-cancer therapy until their cancer is no longer responding.

The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective.

Participants will be involved in this study for up to 4 years. During this time, they will come into the clinic between 1 to 4 times in each 21-day or 28-day cycle. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.

Study Overview

• Status: Recruiting
• Conditions: Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Carcinoma, Pancreatic Ductal
• Intervention / Treatment: Drug: PF-07934040; Combination product: Gemcitabine; Combination product: Nab-paclitaxel; Combination product: Cetuximab; Combination product: Fluorouracil; Combination product: Oxaliplatin; Combination product: Leucovorin; Combination product: Bevacizumab; Combination product: Pembrolizumab; Combination product: pemetrexed; Combination product: Cisplatin; Combination product: Paclitaxel; Combination product: Carboplatin; Combination product: Sasanlimab

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pfizer CT.gov Call Center; Phone Number: 1-800-718-1021; Email: ClinicalTrials.gov_Inquiries@pfizer.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Not yet recruiting
      • Beijing Cancer hospital
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Recruiting
    • Pan American Center for Oncology Trials, LLC
• United States
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Recruiting
      • Highlands Oncology Group, PA
    • Rogers, Arkansas, United States, 72758
      • Recruiting
      • Highlands Oncology Group, PA
    • Springdale, Arkansas, United States, 72762
      • Recruiting
      • Highlands Oncology Group
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope Investigational Drug Service (IDS)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital - Anschutz Outpatient Pavilion
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20016
      • Recruiting
      • Sibley Memorial Hospital
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • START Midwest
  • Missouri
    • City of Saint Peters, Missouri, United States, 63376
      • Recruiting
      • Siteman Cancer Center - St Peters
    • Creve Coeur, Missouri, United States, 63141
      • Recruiting
      • Siteman Cancer Center - West County
    • Florissant, Missouri, United States, 63031
      • Recruiting
      • Siteman Cancer Center - North County
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
    • St Louis, Missouri, United States, 63108
      • Recruiting
      • Siteman Cancer Center
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Barnes-Jewish Hospital
    • St Louis, Missouri, United States, 63129
      • Recruiting
      • Siteman Cancer Center - South County
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Medical Center, lnvestigational Chemotherapy Service
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic Taussig Cancer Center
    • West Chester, Ohio, United States, 45069
      • Recruiting
      • West Chester Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • Miriam Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor.

ECOG PS 0 or 1

• Presence of at least 1 measurable lesion based on RECIST version 1.1 that has not been previously irradiated.

• Documentation of mutated KRAS gene

  1. PDAC, CRC, Other tumor types: Confirmed KRAS mutation, any variant
  2. NSCLC: Confirmed KRAS mutation, any variant except previously treated G12C. If driver mutation, must have failed precision medicine therapy [eg, inhibitors of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), c-ros oncogene 1 (ROS1), and others].

• Part 1 and Part 2a: Participant must have progressed on standard treatment(s) for which no additional, effective therapy is available.

  1. PDAC (2-3L): Participants must have received and radiologically progressed on prior lines of systemic therapy for metastatic pancreatic adenocarcinoma. If participants received prior neoadjuvant or adjuvant chemotherapy and progressed within 6 months of the last dose, then this should be considered as a prior line of systemic therapy.
  2. NSCLC (2-3L): Participants must have received prior lines of anti-cancer treatment and progressed on at least a platinum-containing chemotherapy regimen or ICI. Participants may have had only one or two prior lines of therapy in the advanced/metastatic setting. For participants with EGFR, ALK, or other genomic tumor alterations, participants must have progressed on approved therapy for these alterations.
  3. CRC (2-3L): Participants must have had one or two prior lines of therapy for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, oxaliplatin, and/or irinotecan for one prior treatment, exposure to VEGF/VEGF receptor (VEGFR) inhibitor is optional;
  4. Other tumors: Participants, in the judgment of the investigator, must have progressed or become intolerant to all available standard therapies, or have refused such therapy.

• Part 2b:

  1. PDAC (1L) Cohort A2: Participants must not have received prior chemotherapy for metastatic disease. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant treatment or neoadjuvant therapy, the participant would be considered 2L, and not 1L.
  2. CRC (2-3L) Cohort B2: Participants must have had one or two prior systemic treatment regimens for mCRC. For either one or two prior treatments, these regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin; for one prior treatment, exposure to a VEGF/VEGF receptor (VEGFR) inhibitor is optional.
  3. CRC (1L) Cohort B3/B4: Participants must not have received prior therapy for metastatic disease and not be a candidate for other targeted therapy or immunotherapy. Participant could have received neoadjuvant therapy, adjuvant therapy, or adjuvant chemo-radiotherapy. If relapse occurred within 6 months of last dose of adjuvant or neoadjuvant therapy, then the participant would be considered 2L, and not 1L.
  4. NSCLC (1L) Cohort C2: Participants must have a TPS ≥50% and must not have received prior systemic treatment setting.
  5. NSCLC (1L) Cohort C3: Participants with any TPS and must not have received prior systemic treatment setting.

Exclusion Criteria:

• Active or history of pneumonitis/ILD or pulmonary fibrosis requiring treatment with systemic steroid therapy.
• Diagnosis of immunodeficiency or an active autoimmune disease that require systemic treatment with chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy in the past 2 years.
• Sensory peripheral neuropathy ≥Grade 2
• Active or history of clinically significant gastrointestinal (GI) disease (including but not limited to inflammatory GI disease [eg, ulcerative colitis, Crohn's disease, inflammatory bowel disease], immune-mediated colitis, peptic ulcer disease, GI bleeding, chronic diarrhea) and other conditions that are unresolved and/or may increase the risk associated with study participation or study treatment administration.
• Active bleeding disorder, including GI bleeding, as evidenced by hematemesis, significant hemoptysis or melena in the past 6 months.
• Major surgery or completion of radiation therapy ≤4 weeks prior to enrollment/randomization or radiation therapy that included >30% of the bone marrow.
• Known sensitivity or contraindication to any component of study intervention (PF 07934040, gemcitabine, nab-paclitaxel, cetuximab, bevacizumab, FOLFOX, 5-FU, pembrolizumab, cisplatin, carboplatin, pemetrexed, SHP2 inhibitor(s), cyclin-dependent kinase (CDK) inhibitor(s), antibody drug conjugates (ADCs) or EGFR inhibitor(s)).
• Hematologic abnormalities.

• Renal impairment.

  • Hepatic abnormalities.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1; PF-07934040 Monotherapy Dose Escalation PF-07934040 monotherapy at prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040
Experimental: Part 2a Cohort A1; Monotherapy dose expansion in 2-3L PDAC. PF-07934040 at prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040
Experimental: Part 2a Cohort B1; Monotherapy dose expansion in 2-3L CRC. PF-07934040 at prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040
Experimental: Part 2a Cohort C1; Monotherapy dose expansion in 2-3L NSCLC. PF-07934040 at prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040
Experimental: Part 2b Cohort A2; Combination (PF-07934040 + Gemcitabine + Nab-paclitaxel) dose escalation/expansion in 1L PDAC. Prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040; Combination product: Gemcitabine; Chemotherapy (antimetabolite); Other Names: Gemzar; Combination product: Nab-paclitaxel; Taxane-type Chemotherapy; Other Names: Abraxane
Experimental: Part 2b Cohort B2; Combination (PF-07934040 + Cetuximab) dose escalation/expansion in 2-3L CRC Prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040; Combination product: Cetuximab; Monoclonal Antibody (EGFR Inhibitor); Other Names: Erbitux
Experimental: Part 2b Cohort B3; Combination (PF-07934040 + FOLFOX + Bevacizumab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040; Combination product: Fluorouracil; Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog); Other Names: 5-FU; 5-fluorouracil; Combination product: Oxaliplatin; Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent); Other Names: Eloxatin; Combination product: Leucovorin; Part of FOLFOX chemotherapy regimen Folic Acid Analog; Other Names: Wellcovorin; Folinic Acid; calcium folinate; Leucovorin Calcium; Combination product: Bevacizumab; VEG-F inhibitor; Other Names: Avastin; Zirabev
Experimental: Part 2b Cohort C3; Combination (PF-07934040 + Pembro + Platinum Chemo) dose escalation/expansion in 1L NSCLC (any TPS) Prescribed dose and frequency in 21-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040; Combination product: Pembrolizumab; immune checkpoint inhibitor (PD-1 inhibitor); Other Names: Keytruda; MK-3475; Lambrolizumab; Pembro; Combination product: pemetrexed; Can be used in Platinum-based Chemotherapy regimen Antimetabolite; Other Names: Alimta; Combination product: Cisplatin; Can be used as part of Platinum-based chemotherapy regimen Platinum-based antineoplastic (alkylating agent); Other Names: Cisplatinum; Platinol; neoplatin; Combination product: Paclitaxel; Can be used in Platinum-based chemotherapy regimen Taxane; Other Names: Taxol; Onxol; Combination product: Carboplatin; Can be used as part of a platinum-based chemotherapy regimen platinum containing compound (alkylating agent); Other Names: Paraplatin; Stricarb
Experimental: Part 2a Cohort D1; Monotherapy dose expansion in Other Indications. PF-07934040 at prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040
Experimental: Part 2b Cohort B4; Combination (PF-07934040 + FOLFOX + Cetuximab) dose escalation/expansion in 1L CRC Prescribed dose and frequency in 28-day cycles	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040; Combination product: Cetuximab; Monoclonal Antibody (EGFR Inhibitor); Other Names: Erbitux; Combination product: Fluorouracil; Part of FOLFOX chemotherapy regimen cytotoxic chemotherapy (antimetabolite and pyrimidine analog); Other Names: 5-FU; 5-fluorouracil; Combination product: Oxaliplatin; Part of FOLFOX Chemotherapy Regimen platinum based compound (alkylating agent); Other Names: Eloxatin; Combination product: Leucovorin; Part of FOLFOX chemotherapy regimen Folic Acid Analog; Other Names: Wellcovorin; Folinic Acid; calcium folinate; Leucovorin Calcium
Experimental: Part 2b Cohort C2; Combination (PF-07934040 + Pembro or Sasanlimab) dose escalation/expansion in 1L NSCLC (TPS ≥ 50%) Prescribed dose and frequency in 21-day cycles (for pembro) or 28-day cycles (for sasanlimab)	Drug: PF-07934040; panKRAS inhibitor; Other Names: PF-4040; Combination product: Pembrolizumab; immune checkpoint inhibitor (PD-1 inhibitor); Other Names: Keytruda; MK-3475; Lambrolizumab; Pembro; Combination product: Sasanlimab; immune checkpoint inhibitor (PD-1 inhibitor); Other Names: PF-06081591

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 & 2: Incidence of Adverse Events (AEs)	An adverse event (AE) was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.	Start of treatment up to 30 days after last dose or start of new anticancer therapy (whichever occurs first)
PART 1 & 2: Number of participants with laboratory abnormalities	Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).	From start of treatment up to 30 days after last dose or start of new anticancer therapy, whichever occurred first
Part 1: Number of participants with Dose-limiting toxicities (DLT)	Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes	Baseline up to 28 days
Part 2: Objective Response - Number of Participants With Objective Response (alone or in combination)	Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for overall response rate (ORR), progression free survival (PFS), and overall survivor (OS) assessed by the Investigator.	Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1 & 2: Maximum Observed Serum Concentration (Cmax)	Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.	baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Part 1& 2: Time to Reach Maximum Observed Serum Concentration (Tmax)	Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.	Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Part 1 & 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Evaluate the single and multiple dose PK of PF-07934040 as monotherapy, or in combination with other anti-tumor agents.	Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Part 1 & 2: Changes in pERK levels	Evaluates the intended mechanism of action (MoA) modulation of KRAS inhibition and target engagement effect of PF-07934040 in peripheral blood of participants with advanced solid tumor malignancies.	Baseline through end of Cycle 1 (All cycles are 28 days except part 2b Cohort C2 which are 21 days)
Part 1: Objective Response - Number of Participants With Objective Response	Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator including overall response rate (ORR), progression free survival (PFS), and overall survival (OS).	Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years
Part 1: Effect of Food on Cmax	Evaluate the effect of food on Cmax of PF-07934040 as monotherapy.	Baseline through end of Cycle 1 (All cycles are 28 days)
Part 1: Effect of Food on Tmax	Evaluate the effect of food on Tmax of PF-07934040 as monotherapy.	Baseline through end of Cycle 1 (All cycles are 28 days)
Part 1: Effect of Food on AUClast	Evaluate the effect of food on AUClast of PF-07934040 as monotherapy.	Baseline through end of Cycle 1 (All cycles are 28 days)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Estimated): January 19, 2028
• Study Completion (Estimated): January 18, 2029

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Lung Cancer; NSCLC; Non-Small Cell Lung Cancer; Colorectal Cancer; Carcinoma, Non-Small-Cell Lung; Rectal Cancer; Colon Cancer; Colorectal Carcinoma; Colorectal Neoplasms; KRAS; CRC; Non-Small Cell Lung Carcinoma; MSS CRC; Colorectal Tumors; Neoplasms, Colorectal; pancreatic ductal adenocarcinoma; Non-Small-Cell Lung Carcinoma; Nonsmall Cell Lung Cancer; Carcinoma, Pancreatic Ductal; G12V; G12C; KRAS gene mutation; G12D; G12R; G12S; G13D; Q61H; Pancreatic Ductal Carcinoma; Carcinoma, Ductal, Pancreatic; Duct-Cell Carcinoma of the Pancreas; Duct-Cell Carcinoma, Pancreas; Ductal Carcinoma of the Pancreas; Pancreatic Duct Cell Carcinoma; PADC
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Lung Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Carcinoma; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Carcinoma, Ductal; Rectal Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Colonic Neoplasms; Carcinoma, Non-Small-Cell Lung; Carcinoma, Pancreatic Ductal; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Platinum Compounds; Albumins; Oxaliplatin; Bevacizumab; Albumin-Bound Paclitaxel; Pemetrexed; Cetuximab; Gemcitabine; Fluorouracil; Carboplatin; Leucovorin; Paclitaxel; Cisplatin; pembrolizumab; 130-nm albumin-bound paclitaxel
• Other Study ID Numbers: C5421001; NCT06447662 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No