Many people think of clinical trials as a last-ditch effort for cancer patients.
In 2025, amid a flurry of new treatments enabling people diagnosed with cancer to live longer and better, newly-designed clinical trials are providing new options and hope for patients and their families.
In the Inova Schar Cancer Institute’s Phase One Program, and other forward-thinking cancer research and treatment facilities, the goal is to develop and test drugs and protocols that zoom in on a patient’s particular cancer, without having to resort to chemotherapy, which effectively kills cancer cells, but also affects healthy cells.
Thoracic oncologist Amin Benyounes — who has been my oncologist since I was diagnosed with stage 4 lung cancer in late 2022 — and gastrointestinal oncologist Ray Wadlow, lead the Phase One program at Inova Schar, in Fairfax, Virginia. (Just a reminder — after a few months of targeted therapy and a lobectomy, I’ve been cancer-free since May 2023, while continuing my one-pill-a-day regimen.)
“There are a lot of new developments, novel trial designs, looking at getting these agents to patients earlier in their cancer journeys, with much greater expectations of clinical benefits, so that we really have a more realistic chance of helping people live longer, better lives,” Wadlow said.
In the previous drug development paradigm, experimental cancer treatments were only offered to patients with late-stage disease, after all standards of care had failed, at low dosages for safety, which provided little benefit.
While chemotherapy remains one of the most powerful ways to kill cancer cells, many of the drugs in clinical trials aim to spare — or at least delay — subjecting patients to often uncomfortable side effects of chemo.
“There are a lot of diseases where the standard of care actually is quite good, and so sometimes it’s hard to beat that,” said Benyounes. “But oftentimes we’re able to bring new drugs that improve upon the standard of care.”
Many of drugs in trials target genetic mutations that trigger specific cancers — often referred to as precision medicine. “We’re looking for novel therapies that are effective against cancer, and with minimal toxicities,” said Wadlow.
“The other area of excitement, which has really revolutionized the care of many people, is harnessing the immune system,” through immunotherapy, said Wadlow. While not effective against all cancers, it can “tip the scales back in favor of the immune system, in its battle, if you will, against the cancer cell.”
In quantifying the successes of novel drugs, Benyounes cites the CROWN study, when the targeted therapy, lorlatinib was compared to an earlier therapy, crizotinib for patients with ALK positive lung cancer.
Patients on lorlatinib went much longer without their cancer getting worse, Benyounes said. Most people on lorlatinib hadn’t seen their cancer get worse after five years, while patients on crizotinib started worsening after about 9 months on average.
“Improving lung health means giving patients access to the right treatment at the right time that is aligned with their diagnostic needs. In the past decade, clinical trials have contributed to rapidly advancing research, which has led to more individuals living with lung cancer exceeding the five-year survival rate than ever before — offering hope, improving the standard of care and maintaining quality of life through more personalized care,” said Deb Brown, chief mission officer of the American Lung Association.
Fears, realities in considering a clinical trial
In today’s climate, an oncologist will often discuss the potential benefits and drawbacks of enrolling in a clinical trial at a point in which a patient’s current treatment stops working, resulting in cancer spreading or recurring.
“The fears that come up are certainly the fear of the unknown,” said Benyounes. “Will this make me feel worse, will it make me feel sick, could it hurt more than it would help? Will my kids or my partner have to bear the burden of me feeling sick?”
In order to enroll in trial, patients have to meet certain criteria, including previous treatments and their general health.
The National Institutes of Health’s ClinicalTrials.gov database allows a user to enter searchable terms, to find ongoing clinical trials for a particular disease.
Benyounes and Wadlow discuss with their patients what to expect, if they enroll in a trial.
“We’re fortunate that patients trust us with their health. The way I would do it is, ‘If you were my loved one, I think this might be a better option than what is available,'” with current standard of care treatments, Benyounes said.
“They place a lot of trust in us, but they’re vulnerable,” said Wadlow. “People are sick, and they’re in situations they didn’t want to be in, they didn’t ask to be in.”
Patients in a clinical trial are monitored closely.
“It’s not uncommon for patients to be seen multiple times per week for the earliest stage trials, or certainly on a weekly basis, even if the drug is only being given less frequently, for example, every three weeks,” said Wadlow.
Benyounes said patients in a study usually stay on a drug as long as it is effective. For drugs that make it to market after FDA approval, they switch to the commercially available version of the medication.
If a patient’s cancer spreads or side effects become intolerable, “We would always advise that they come off trial,” said Wadlow. “If we are concerned that it might not be the best thing for them going forward.”
Benyounes said “our role is to advocate for the patient, not for the trial.”
With clinical trials affording the possibilities for longer survival, with fewer side effects, some patients ask, “What if I get my hopes up, and it doesn’t work?”
According to Benyounes: “My answer to that is usually, ‘We have to take things one step at a time.'”
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